Customized Circulating Tumor DNA Testing for Cervical Cancer Recurrence Surveillance and Treatment Decisions

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to monitor and treat cervical cancer using a test called ctDNA, which looks for tiny pieces of cancer DNA in the blood. The goal is to create a personalized approach to track cancer recurrence (return of the cancer) and determine the best treatment options for patients with advanced or recurrent cervical cancer. Researchers believe that by customizing the ctDNA test, they can better understand how a patient's cancer behaves and tailor immunotherapy (a type of treatment that helps the immune system fight cancer) accordingly.

To be eligible for this trial, participants need to be women aged 18 or older who have been diagnosed with locally advanced or recurrent cervical cancer and have not received any previous cancer treatments. They must also be willing to provide consent for the trial and undergo certain tests. If you join this study, you can expect to contribute to important research that may lead to improved monitoring and treatment strategies for cervical cancer. Please note that the trial is not yet recruiting participants, so further information will be available once it begins.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. be willing and able to provide written informed consent/consent for the trial.
• • 2. Be 18 years of age or older on the date of signing the informed consent form.
• • 3. patients with histologically or cytologically documented locally advanced, advanced, or first recurrent cervical cancer. For treatment-naive patients, 4) no previous cancer treatment including chemotherapy or radiotherapy; Patients with an initial recurrence had not received any other cancer treatment, including chemotherapy or radiotherapy, after the diagnosis of an initial recurrence before enrollment.
• • 5) measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• • 6) willing and able to provide tumor lesions or excisional biopsy tissue. 7) a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. Demonstrate adequate organ function.
• • 8) a negative pregnancy test in a fertile female patient.
• Exclusion Criteria:
• • 1. be diagnosed as immunocompromised or receiving systemic steroid therapy or any other form of immunosuppressive therapy.
• • 2. a known history of active tuberculosis (Mycobacterium tuberculosis).
• • 3. have a known other malignancy that is progressing or requires active treatment.
• • 4. known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• • 5. have an active autoimmune disease requiring systemic treatment within the past 2 years.
• • 6. known history or any evidence of active noninfectious pneumonia.
• • 7. active infection requiring systemic therapy.
• • 8. there is historical or current evidence of any condition, treatment, or laboratory abnormality that could confound the trial results, interfere with the patient's participation throughout the trial, or that the treatment investigator believes participation would not be in the patient's best interest.
• • 9. psychiatric or substance abuse disorders known to interfere with compliance with trial requirements.
• • 10. be pregnant or breastfeeding, or expect to become pregnant or give birth to a child within the intended duration of the trial.
• • 11. had a known history of human immunovirus (HIV) (HIV 1/2 antibodies).
• • 12. known to have active hepatitis B (e.g., HBsAg reactive) or hepatitis C.
• • 13. received live vaccine within 30 days of planned initiation of study treatment.