NCT06713512 InvEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
| NCT ID | NCT06713512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust |
| Condition | Chronic Obstructive Lung Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-12-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to understand the role of oestrogen in patients with asthma and Chronic Obstructive Pulmonary Disorder (COPD). Therefore, what is the effect of oestrogen in these participants compared to controls (those without disease). The study hypothesises that oestrogen loss in patients with asthma and COPD causes accelerated lung function decline and changes to lung structure. It will investigate if this is mediated by inflammation, immune host response or elastin and collagen changes. It is an observational prospective cohort study aiming to recruit healthy controls, and people with asthma or COPD), and/or the menopause.
Eligibility Criteria
Inclusion Criteria: 1. Men and women aged \> 18 years. 2. For female participants: pre-menopausal, peri-menopausal and post-menopausal women can all be included. 3. Participants willing and able to give informed consent for participation in the study. 4. Healthy controls \<10 pack year history (participants without Asthma or COPD). Exclusion Criteria: 1. Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus. 2. Alcohol or recreational drug abuse, is defined as when the use is harmful as per NHS definition. 3. History of psychiatric, medical, or surgical disorders. 4. Pregnant 5. Unable to provide written informed consent 6. History of advanced medical conditions with an expected prognosis of \< 3 years. 7. Patients with a history of active cancer. 8. Patients on long term oxygen (ambulatory oxygen).
Contact & Investigator
Mona Bafadhel
PRINCIPAL INVESTIGATOR
King's College London
Frequently Asked Questions
Who can join the NCT06713512 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Chronic Obstructive Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06713512 currently recruiting?
Yes, NCT06713512 is actively recruiting participants. Contact the research team at gillian.radcliffe@gstt.nhs.uk for enrollment information.
Where is the NCT06713512 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06713512 clinical trial?
NCT06713512 is sponsored by Guy's and St Thomas' NHS Foundation Trust. The principal investigator is Mona Bafadhel at King's College London. The trial plans to enroll 100 participants.