NCT06019286

Brief Summary

•Examine whether COPD is associated with accelerated aging using a biological marker of aging and dermatological score

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 19, 2023

Last Update Submit

August 25, 2023

Conditions

Keywords

premature aging

Outcome Measures

Primary Outcomes (3)

  • 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

    1 week

  • Level of GH and RDW in relation to COPD patient age.

    measuring level of GH and in COPD patients and control group

    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

    1 week

Study Arms (2)

COPD cases

COPD patients for whom biological marker and dermatological score will be measured

Diagnostic Test: SCINEXA score

Control group

non COPD subjects for whom biological marker and dermatological score will be measured

Diagnostic Test: SCINEXA score

Interventions

SCINEXA scoreDIAGNOSTIC_TEST

\- 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

Also known as: growth hormone level
COPD casesControl group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 37114105BACKGROUND
  • 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: 25614163BACKGROUND
  • 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: 35943713BACKGROUND
  • 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: 19059763BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAging, Premature

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Eman Fathy Ahmed, Dr.

    Assiut University

    STUDY CHAIR
  • Heba Hassan Sayed, DR.

    Assiut University

    STUDY CHAIR
  • Salma Mokhtar Osman, DR.

    Assiut University

    STUDY CHAIR
  • Amal Adel Rayan, Dr.

    Assiut University

    STUDY CHAIR

Central Study Contacts

Sahar R Mahmoud, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 19, 2023

First Posted

August 31, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

August 31, 2023

Record last verified: 2023-08