COPDNCT06019286
Novel Predictors of Premature Aging in COPD Patients
An observational study of COPD, run by Assiut University.
Trial summary
•Examine whether COPD is associated with accelerated aging using a biological marker of aging and dermatological score Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- SCINEXA score
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with COPD attending outpatient clinic either for follow up or newly diagnosed are eligible for inclusion as cases. Control group is non COPD healthy controls.
Who may be able to join
- Patients with COPD attending outpatient are eligible for inclusion as cases. Control group is non COPD healthy controls.
Who cannot join
- • Patients refused to participate in the study.
- Patients unable to perform the spirometry test.
- Patients had a history of hormone disorder or malignant disease.
- Patients received hormone replacement therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Novel Predictors of Premature Aging in COPD Patients: SCINEXA Score and Laboratory Markers
•Examine whether COPD is associated with accelerated aging using a biological marker of aging and dermatological score
Read the detailed description
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.
- Conditions
- COPD
- Being tested
- SCINEXA score
- Keywords
- premature aging
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Aging, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCINEXA scoreDiagnostic test
Also called growth hormone level
- 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
| Study group | Role | What they receive |
|---|---|---|
| COPD cases | COPD patients for whom biological marker and dermatological score will be measured Receives: Diagnostic Test: SCINEXA score | |
| Control group | non COPD subjects for whom biological marker and dermatological score will be measured Receives: Diagnostic Test: SCINEXA score |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCINEXA score in relation to COPD patient chronological age.
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
Measured: 1 week
Level of GH and RDW in relation to COPD patient age.
measuring level of GH and in COPD patients and control group
Measured: 1 week
Comparing level of GH with the chronological age
Compare level of GH with the chronological age of patients and controls to detected premature aging
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Refaat Mahmoud, Assiut University
- Investigators
- Eman Fathy Ahmed, Dr., Study chair, Assiut UniversityHeba Hassan Sayed, DR., Study chair, Assiut UniversitySalma Mokhtar Osman, DR., Study chair, Assiut UniversityAmal Adel Rayan, Dr., Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019286
- Sponsor's protocol ID
- premature aging in COPD
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37114105Barnes 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.
PubMed 25614163Jiang 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.
PubMed 35943713Vierkotter 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.
PubMed 19059763
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Predictors of Premature Aging in COPD Patients: SCINEXA Score and Laboratory Markers
- ClinicalTrials.gov ID
- NCT06019286
- Acronym / sponsor ID
- premature aging in COPD
- Conditions
- COPD
- Keywords
- premature aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
•Examine whether COPD is associated with accelerated aging using a biological marker of aging and dermatological score
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD cases | – | Diagnostic Test: SCINEXA scoreCOPD patients for whom biological marker and dermatological score will be measured |
| Control group | – | Diagnostic Test: SCINEXA scorenon COPD subjects for whom biological marker and dermatological score will be measured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD attending outpatient clinic either for follow up or newly diagnosed are eligible for inclusion as cases. Control group is non COPD healthy controls.
Key inclusion criteria (1 listed)
- Patients with COPD attending outpatient are eligible for inclusion as cases. Control group is non COPD healthy controls.
Key exclusion criteria (4 listed)
- • Patients refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCINEXA scoreAlso: growth hormone level- 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 | Diagnostic test | COPD cases, Control group |
Primary outcome
SCINEXA score in relation to COPD patient chronological age.
Time frame: 1 week
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
Level of GH and RDW in relation to COPD patient age.
Time frame: 1 week
measuring level of GH and in COPD patients and control group
Comparing level of GH with the chronological age
Time frame: 1 week
Compare level of GH with the chronological age of patients and controls to detected premature aging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 37114105Brat 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.
- Background: PubMed 25614163Barnes 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.
- Background: PubMed 35943713Jiang 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.
- Background: PubMed 19059763Vierkotter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Fathy Ahmed, Dr. study chair
Assiut University
Heba Hassan Sayed, DR. study chair
Assiut University
Salma Mokhtar Osman, DR. study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sahar R Mahmoud, Dr. (01002866364, farida62014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCINEXA score in relation to COPD patient chronological age. (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019286, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.