xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06019286</url>
    </required_header>
    <id_info>
      <org_study_id>premature aging in COPD</org_study_id>
      <nct_id>NCT06019286</nct_id>
    </id_info>
    <brief_title>Novel Predictors of Premature Aging in COPD Patients</brief_title>
    <official_title>Novel Predictors of Premature Aging in COPD Patients: SCINEXA Score and Laboratory Markers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        •Examine whether COPD is associated with accelerated aging using a biological marker of aging&#xD;
        and dermatological score&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic Obstructive Pulmonary Disease (COPD) results from gene(G)-environment(E) interactions&#xD;
        occurring over the lifetime(T) of the individual (GETomics) that can damage the lungs and/or&#xD;
        alter their normal development/aging processes.&#xD;
  &#xD;
        In COPD, processes including oxidant/antioxidant, protease/antiprotease, and proliferative/&#xD;
        antiproliferative balance, and the control of the inflammatory response become dysfunctional,&#xD;
        as in aging. A close relationship between the pathogenesis of COPD and aging has been&#xD;
        reviewed, and an increase regarding aging has been identified Aging is defined as a&#xD;
        time-dependent progressive loss of physiological integrity, resulting in impaired function&#xD;
        and increased vulnerability to death many chronic diseases are dependent on age and encompass&#xD;
        physiological mechanisms related to the aging process The interconnection of the different&#xD;
        markers of aging has not yet been studied in clinical subjects. We hypothesized that these&#xD;
        markers, representing different interrelated aspects of the aging process, are altered in a&#xD;
        cohort of COPD patients compared to the control group. These markers include growth&#xD;
        hormone(GH), &quot;Red cell distribution width (RDW) and SCINEXA (SCore for INtrinsic and&#xD;
        EXtrinsic skin Aging) score as a read-out of biological age. SCINEXA is a validated score&#xD;
        which measures the intrinsic and extrinsic factors regarding chronological skin aging and&#xD;
        aging due to chronic exposure to ultraviolet (UV) radiation, Respectively.&#xD;
  &#xD;
        The major feature of aging is the role of hormones as key regulators of human muscle&#xD;
        metabolism and physical function. Growth hormone (GH) actions impact growth, metabolism, and&#xD;
        body composition and have been associated with aging and Longevity. While, red cell&#xD;
        distribution width (RDW), a part of the standard complete blood count (CBC), is a simple and&#xD;
        non-invasive parameter that can be used as a biomarker in evaluating the severity and&#xD;
        mortality rates in COPD patients in acute attacks. Also, Elevated RDW has been associated&#xD;
        with degenerative conditions in aging.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>SCINEXA score in relation to COPD patient chronological age.</measure>
      <time_frame>1 week</time_frame>
      <description>measuring SCINEXA score (Score for Intrinsic and Extrinsic skin Aging) in COPD patients and in control group and comparing it with chronological age. - 18 signs of extrinsic aging, each item will be scored as 0 (none), 1 (mild), 2 (moderate) or 3 (severe). For some items (uneven pigmentation, cutis rhomboidalis nuchae, elastosis, comedones and cysts of Favre Racouchot, and malignant skin tumors, a binary scale was used: (yes) or (no). Maximun possible score is 54</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of GH and RDW in relation to COPD patient age.</measure>
      <time_frame>1 week</time_frame>
      <description>measuring level of GH and in COPD patients and control group</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparing level of GH with the chronological age</measure>
      <time_frame>1 week</time_frame>
      <description>Compare level of GH with the chronological age of patients and controls to detected premature aging</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>COPD cases</arm_group_label>
      <description>COPD patients for whom biological marker and dermatological score will be measured</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>non COPD subjects for whom biological marker and dermatological score will be measured</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>SCINEXA score</intervention_name>
      <description>- 18 signs of extrinsic aging of SCINEXA score: sunburn, freckles, actinic lentigo, hyperpigmentation and/or melasma, change in phototype, yellowness, pseudoscars, coarse wrinkles, solar elastosis, cutis rhomboidalis, elastosis, comedones and cysts of Favre-Racouchot, xerosis, teleangectasias, permanent erythema, actinic keratosis, basal cell carcinoma, squamous cell carcinoma and malignant melanoma (extrinsic SCINEXA score). Each item will be scored as 0 (none), 1 (mild), 2 (moderate) or 3 (severe). For some items (uneven pigmentation, cutis rhomboidalis nuchae, elastosis, comedones and cysts of Favre Racouchot, and malignant skin tumors, a binary scale was used: (yes) or (no). Maximun possible score is 54</description>
      <arm_group_label>COPD cases</arm_group_label>
      <arm_group_label>Control group</arm_group_label>
      <other_name>growth hormone level</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with COPD attending outpatient clinic either for follow up or newly diagnosed are&#xD;
          eligible for inclusion as cases. Control group is non COPD healthy controls.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with COPD attending outpatient are eligible for inclusion as cases. Control&#xD;
               group is non COPD healthy controls.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Patients refused to participate in the study.&#xD;
  &#xD;
                 -  Patients unable to perform the spirometry test.&#xD;
  &#xD;
                 -  Patients had a history of hormone disorder or malignant disease.&#xD;
  &#xD;
                 -  Patients received hormone replacement therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Eman Fathy Ahmed, Dr.</last_name>
      <role>Study Chair</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Heba Hassan Sayed, DR.</last_name>
      <role>Study Chair</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Salma Mokhtar Osman, DR.</last_name>
      <role>Study Chair</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Amal Adel Rayan, Dr.</last_name>
      <role>Study Chair</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sahar R Mahmoud, Dr.</last_name>
      <phone>01002866364</phone>
      <email>farida62014@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Brat K, Svoboda M, Zatloukal J, Plutinsky M, Volakova E, Popelkova P, Novotna B, Dvorak T, Koblizek V. Prognostic Properties of the GOLD 2023 Classification System. Int J Chron Obstruct Pulmon Dis. 2023 Apr 20;18:661-667. doi: 10.2147/COPD.S410372. eCollection 2023.</citation>
      <PMID>37114105</PMID>
    </reference>
    <reference>
      <citation>Barnes PJ. Mechanisms of development of multimorbidity in the elderly. Eur Respir J. 2015 Mar;45(3):790-806. doi: 10.1183/09031936.00229714. Epub 2015 Jan 22.</citation>
      <PMID>25614163</PMID>
    </reference>
    <reference>
      <citation>Jiang Z, Han X, Wang Y, Hou T, Dong Y, Han X, Welmer AK, Launer LJ, Du Y, Qiu C. Red cell distribution width, anemia, and lower-extremity physical function among rural-dwelling older adults. Aging Clin Exp Res. 2022 Oct;34(10):2483-2491. doi: 10.1007/s40520-022-02187-9. Epub 2022 Aug 9.</citation>
      <PMID>35943713</PMID>
    </reference>
    <reference>
      <citation>Vierkotter A, Ranft U, Kramer U, Sugiri D, Reimann V, Krutmann J. The SCINEXA: a novel, validated score to simultaneously assess and differentiate between intrinsic and extrinsic skin ageing. J Dermatol Sci. 2009 Mar;53(3):207-11. doi: 10.1016/j.jdermsci.2008.10.001. Epub 2008 Dec 6.</citation>
      <PMID>19059763</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Sahar Refaat Mahmoud</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <keyword>premature aging</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Premature Birth</mesh_term>
      <mesh_term>Aging, Premature</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hormones</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06019286
  org study id: premature aging in COPD
  nct id: NCT06019286
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  •Examine whether COPD is associated with accelerated aging using a biological marker of aging
        and dermatological score
  Chronic Obstructive Pulmonary Disease (COPD) results from gene(G)-environment(E) interactions
        occurring over the lifetime(T) of the individual (GETomics) that can damage the lungs and/or
        alter their normal development/aging processes.
  
        In COPD, processes including oxidant/antioxidant, protease/antiprotease, and proliferative/
        antiproliferative balance, and the control of the inflammatory response become dysfunctional,
        as in aging. A close relationship between the pathogenesis of COPD and aging has been
        reviewed, and an increase regarding aging has been identified Aging is defined as a
        time-dependent progressive loss of physiological integrity, resulting in impaired function
        and increased vulnerability to death many chronic diseases are dependent on age and encompass
        physiological mechanisms related to the aging process The interconnection of the different
        markers of aging has not yet been studied in clinical subjects. We hypothesized that these
        markers, representing different interrelated aspects of the aging process, are altered in a
        cohort of COPD patients compared to the control group. These markers include growth
        hormone(GH), "Red cell distribution width (RDW) and SCINEXA (SCore for INtrinsic and
        EXtrinsic skin Aging) score as a read-out of biological age. SCINEXA is a validated score
        which measures the intrinsic and extrinsic factors regarding chronological skin aging and
        aging due to chronic exposure to ultraviolet (UV) radiation, Respectively.
  
        The major feature of aging is the role of hormones as key regulators of human muscle
        metabolism and physical function. Growth hormone (GH) actions impact growth, metabolism, and
        body composition and have been associated with aging and Longevity. While, red cell
        distribution width (RDW), a part of the standard complete blood count (CBC), is a simple and
        non-invasive parameter that can be used as a biomarker in evaluating the severity and
        mortality rates in COPD patients in acute attacks. Also, Elevated RDW has been associated
        with degenerative conditions in aging.
  observational model: Case-Control
  time perspective: Prospective
  measure: SCINEXA score in relation to COPD patient chronological age.
  time frame: 1 week
  description: measuring SCINEXA score (Score for Intrinsic and Extrinsic skin Aging) in COPD patients and in control group and comparing it with chronological age. - 18 signs of extrinsic aging, each item will be scored as 0 (none), 1 (mild), 2 (moderate) or 3 (severe). For some items (uneven pigmentation, cutis rhomboidalis nuchae, elastosis, comedones and cysts of Favre Racouchot, and malignant skin tumors, a binary scale was used: (yes) or (no). Maximun possible score is 54
  measure: Level of GH and RDW in relation to COPD patient age.
  time frame: 1 week
  description: measuring level of GH and in COPD patients and control group
  measure: Comparing level of GH with the chronological age
  time frame: 1 week
  description: Compare level of GH with the chronological age of patients and controls to detected premature aging
  arm group label: COPD cases
  description: COPD patients for whom biological marker and dermatological score will be measured
  arm group label: Control group
  description: non COPD subjects for whom biological marker and dermatological score will be measured
  intervention type: Diagnostic Test
  intervention name: SCINEXA score
  description: - 18 signs of extrinsic aging of SCINEXA score: sunburn, freckles, actinic lentigo, hyperpigmentation and/or melasma, change in phototype, yellowness, pseudoscars, coarse wrinkles, solar elastosis, cutis rhomboidalis, elastosis, comedones and cysts of Favre-Racouchot, xerosis, teleangectasias, permanent erythema, actinic keratosis, basal cell carcinoma, squamous cell carcinoma and malignant melanoma (extrinsic SCINEXA score). Each item will be scored as 0 (none), 1 (mild), 2 (moderate) or 3 (severe). For some items (uneven pigmentation, cutis rhomboidalis nuchae, elastosis, comedones and cysts of Favre Racouchot, and malignant skin tumors, a binary scale was used: (yes) or (no). Maximun possible score is 54
  arm group label: COPD cases
  arm group label: Control group
  other name: growth hormone level
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Eman Fathy Ahmed, Dr.
  role: Study Chair
  affiliation: Assiut University
  last name: Heba Hassan Sayed, DR.
  role: Study Chair
  affiliation: Assiut University
  last name: Salma Mokhtar Osman, DR.
  role: Study Chair
  affiliation: Assiut University
  last name: Amal Adel Rayan, Dr.
  role: Study Chair
  affiliation: Assiut University
  last name: Sahar R Mahmoud, Dr.
  phone: 01002866364
  email: farida62014@gmail.com
  citation: Brat K, Svoboda M, Zatloukal J, Plutinsky M, Volakova E, Popelkova P, Novotna B, Dvorak T, Koblizek V. Prognostic Properties of the GOLD 2023 Classification System. Int J Chron Obstruct Pulmon Dis. 2023 Apr 20;18:661-667. doi: 10.2147/COPD.S410372. eCollection 2023.
  PMID: 37114105
  citation: Barnes PJ. Mechanisms of development of multimorbidity in the elderly. Eur Respir J. 2015 Mar;45(3):790-806. doi: 10.1183/09031936.00229714. Epub 2015 Jan 22.
  PMID: 25614163
  citation: Jiang Z, Han X, Wang Y, Hou T, Dong Y, Han X, Welmer AK, Launer LJ, Du Y, Qiu C. Red cell distribution width, anemia, and lower-extremity physical function among rural-dwelling older adults. Aging Clin Exp Res. 2022 Oct;34(10):2483-2491. doi: 10.1007/s40520-022-02187-9. Epub 2022 Aug 9.
  PMID: 35943713
  citation: Vierkotter A, Ranft U, Kramer U, Sugiri D, Reimann V, Krutmann J. The SCINEXA: a novel, validated score to simultaneously assess and differentiate between intrinsic and extrinsic skin ageing. J Dermatol Sci. 2009 Mar;53(3):207-11. doi: 10.1016/j.jdermsci.2008.10.001. Epub 2008 Dec 6.
  PMID: 19059763
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Sahar Refaat Mahmoud
  investigator title: principal investigator
  mesh term: Premature Birth
  mesh term: Aging, Premature
  mesh term: Hormones