Troponin to Detect Major Cardiovasculaire Advserse Events on Immune: a Case Control Retrospective Study
Troponin Test for Heart Issues in Cancer Patients on Immune Therapy
Plain English Summary
Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors is a Not Applicable clinical trial sponsored by Institut Mutualiste Montsouris studying Cancer, Immune Checkpoint Inhibitor, Cardiovascular Biomarkers. This study looks at whether a blood test (troponin) can help find heart problems early in cancer patients receiving immune checkpoint inhibitor therapy. It's for adult patients with solid tumors who are being treated with immune checkpoint inhibitors. Participation involves reviewing existing medical records; no new treatments or procedures are given. Currently, there isn't strong evidence to guide the use of troponin tests for this specific patient group. The trial aims to enroll 300 participants.
Official Summary
Recent guidelines suggest the use of troponin to detect immnune related cardiovascular advserse events in patients treated by immune checkpoint inhibitors for cancer. However, there is no proof that patients on immune checkpoint inhibitors benefit from this active surveillance strategy. The suspicion of cardiovascular events may lead to the interruption of cancer therapies. The TILT study aims at assessing: (i) the efficiency of troponin measurments in asymptomatic patients to prevent the further advent of major cardiovascular events; (ii) its safety in terms of cancer therapy completion.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adult patients with solid tumors who have received or are receiving immune checkpoint inhibitors between 2017 and 2022 can be included. Patients involved in other drug trials (interventional studies) cannot participate. There are no specific age or health requirements beyond the cancer diagnosis and treatment type. This trial is studying Cancer, Immune Checkpoint Inhibitor, Cardiovascular Biomarkers, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures whether using troponin tests can prevent major heart problems over 5 years in these patients. The specific primary outcome measures are: Major cardiovascular event (5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it investigates if a simple blood test can help protect cancer patients from serious heart problems caused by their cancer treatment, without unnecessarily stopping their ca This research targets Cancer, Immune Checkpoint Inhibitor, Cardiovascular Biomarkers, where improved treatment options are needed.
Investor Insight
This observational study aims to validate a diagnostic approach, potentially influencing future clinical practice and the market for cardiovascular monitoring in oncology.
Is This Trial Right for Me?
Ask your doctor if troponin testing is recommended for you and what the results mean. Participation involves reviewing your past medical information, so you won't have new tests or treatments as part of this study. The study team will look at your health records to see if troponin tests were used and if any heart events occurred. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 300 participants
Interventions
- OTHER: No intervention — No intervention
Primary Outcomes
- Major cardiovascular event (5 years)
Secondary Outcomes
- Completion of cancer therapy as scheduled (5 years)
Full Eligibility Criteria
Inclusion Criteria: * All solid cancer patients treated by immune checkpoint inhibitors 2017-2022 Exclusion Criteria: * Patients enrolled in an invterventional study (e.g., pharma trial)
Trial Locations
- Institut Mutualiste Montsouris, Paris, France
Frequently Asked Questions
What is clinical trial NCT06007274?
NCT06007274 is a Not Applicable OBSERVATIONAL study titled "Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors." It is currently completed and is sponsored by Institut Mutualiste Montsouris. The trial targets enrollment of 300 participants.
What conditions does NCT06007274 study?
This trial investigates treatments for Cancer, Immune Checkpoint Inhibitor, Cardiovascular Biomarkers. The primary condition under study is Cancer.
What treatments are being tested in NCT06007274?
The interventions being studied include: No intervention (OTHER). No intervention
What does Not Applicable mean for NCT06007274?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06007274?
This trial is currently "Completed." It started on 2023-07-01. The estimated completion date is 2024-07-01.
Who is sponsoring NCT06007274?
NCT06007274 is sponsored by Institut Mutualiste Montsouris. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06007274?
The trial aims to enroll 300 participants. The trial status is completed.
How is NCT06007274 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06007274?
The primary outcome measures are: Major cardiovascular event (5 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06007274 being conducted?
This trial is being conducted at 1 site, including Paris (France).
Where can I find official information about NCT06007274?
The official record for NCT06007274 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06007274. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06007274 testing in simple terms?
This study looks at whether a blood test (troponin) can help find heart problems early in cancer patients receiving immune checkpoint inhibitor therapy. It's for adult patients with solid tumors who are being treated with immune checkpoint inhibitors.
Why is this trial significant?
This trial matters because it investigates if a simple blood test can help protect cancer patients from serious heart problems caused by their cancer treatment, without unnecessarily stopping their ca
What are the potential risks of participating in NCT06007274?
The main risk is that the study might not find a clear benefit of using troponin tests, or that results could lead to unnecessary worry. Potential side effects are related to the underlying cancer and its treatment, not the study itself, as no new intervention is given. There's a possibility that the study's findings might lead to changes in how doctors monitor heart health in these patients. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06007274?
Ask your doctor if troponin testing is recommended for you and what the results mean. Participation involves reviewing your past medical information, so you won't have new tests or treatments as part of this study. The study team will look at your health records to see if troponin tests were used and if any heart events occurred. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06007274 signal from an investment perspective?
This observational study aims to validate a diagnostic approach, potentially influencing future clinical practice and the market for cardiovascular monitoring in oncology. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves reviewing existing medical records; no new treatments or procedures are given. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.