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ctDNA-Guided Therapy for Lung Cancer (ctDNA Lung RCT Trial)
ctDNA Lung RCT Trial Summary
This trial looks at whether ctDNA can help predict if adjuvant treatment after surgery will decrease the chance of cancer recurrence in lung cancer patients.
ctDNA Lung RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowctDNA Lung RCT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ctDNA Lung RCT Trial Design
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Who is running the clinical trial?
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- I have not received any immune therapy for cancer, such as drugs targeting CTLA-4, PD-1, or PD-L1.My organs and bone marrow are functioning well.My lung cancer type is eligible and lacks targeted treatment options.I haven't had cancer treatment or radiotherapy in the last 3 weeks.I haven't had active autoimmune disorders in the last 3 years, except for allowed conditions like vitiligo, alopecia, stable hypothyroidism, psoriasis not needing systemic treatment, a skin condition not needing systemic therapy, or celiac disease controlled by diet.I've had to stop IV drug treatments more than once due to bad reactions.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I am using effective birth control and will take a pregnancy test before starting treatment.I am not incarcerated and can consent and follow study rules.My blood test shows cancer DNA even after surgery.I haven't taken strong immune-suppressing drugs in the last 14 days, except for minor exceptions like creams or low-dose steroids.I haven't had a live vaccine in the last 30 days and won't get one during the study.You have a history of weakened immune system, organ transplant, or active tuberculosis. If you had tuberculosis before, it must be treated before you can participate in the study.I am a man who will use a condom and avoid donating sperm during the study and for 180 days after.I haven't had any cancer besides non-invasive types in the last 2 years.I have HIV but it's under control with treatment.I haven't had chemotherapy or radiotherapy for my current lung cancer diagnosis.I am not currently in another cancer treatment study but may be in an observational study.I do not have any serious illnesses or conditions that my doctor is still trying to get under control.I am 18 years old or older.I have not had major surgery in the last 28 days or am still recovering from one.I am recommended to have additional chemotherapy after surgery for my cancer.My surgery did not remove all of my cancer.I haven't had a heart attack, severe heart failure, or stroke in the last 3 months.I am fully active or restricted in physically strenuous activity but can do light work.I weigh at least 35 kilograms.You are expected to live for at least 2 years.My lung cancer was surgically removed and was in the early stages or was a larger, multifocal type.
- Group 1: Adjuvant chemo-immunotherapy therapy
- Group 2: Observation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What purpose does the ctDNA blood test typically fulfill?
"The common urinary bladder ailment is usually treated with a ctDNA blood test, which has also been found to be effective for treating small cell lung cancer (SCLC), advanced testicular cancer, and malignant neoplasms."
How extensive is the enrollment of individuals for this experiment?
"Affirmative. Clinicaltrials.gov reveals that this experiment is actively seeking participants, which was first posted on March 28th 2022 and updated recently on April 21st 2022. 66 individuals are being sought out by the single trial site."
Have there been any prior experiences with a ctDNA blood test in clinical trials?
"At present, there are 2048 active trials investigating ctDNA blood tests with 503 at the advanced stage of Phase 3. Most such studies occur in Shanghai; however, they can be found operating in 103733 different sites worldwide."
Are there still vacancies available in this research project?
"Per the data hosted on clinicaltrials.gov, this trial is open for enrollment at present. The original post date was March 28th 2022 and most recent update occurred April 21st 2022."
Is there any potential risk associated with a ctDNA blood examination?
"Taking into consideration the lack of efficacy data and presence of safety information, we have assigned ctDNA blood test a score of 2."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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