Customized Circulating Tumor DNA Testing for Cervical Cancer Recurrence Surveillance and Treatment Decisions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Immunotherapy, Cervical Cancer, CtDNA, Biomarker. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Immunotherapy is the main option for advanced, recurrent and metastatic cervical cancer. However, due to the complex interaction between the immune system and tumors, there is still a lack of effective markers for immunotherapy. Scientists are actively searching for and developing new immunotherapy markers. For cervical cancer diagnosis, it has been shown that ctDNA mutations can reflect HPV integration sites. In terms of cervical cancer prognosis monitoring, cohort studies focused on the application of HPV ctDNA in the field of cervical cancer prognosis monitoring. The aim of this study is to design a customized ctDNA probe for cancer patients through a priori tumor detection method, and to guide recurrence monitoring plan and implement individualized adjuvant therapy according to the results, and to explore personalized biomarkers to guide cervical cancer immunotherapy. To explore the possibility of customized ctDNA detection as a diagnostic marker for cervical cancer. To explore the predictive and prognostic value of customized ctDNA dynamic monitoring. A multi-arm cohort clinical study is planned. To comprehensively study the treatment strategy of advanced and recurrent cervical cancer and explore the related biomarkers through the customized dynamic monitoring of ctDNA in patients with advanced and recurrent cervical cancer. A total of 60 patients with cervical cancer were enrolled.
Primary outcome measures
- Somatic mutation detection by WES [Time frame: from Des 2024 to Oct 2026]
Eligibility criteria
Inclusion criteria
- be willing and able to provide written informed consent/consent for the trial.
- Be 18 years of age or older on the date of signing the informed consent form.
- 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
- be diagnosed as immunocompromised or receiving systemic steroid therapy or any other form of immunosuppressive therapy.
- a known history of active tuberculosis (Mycobacterium tuberculosis).
- have a known other malignancy that is progressing or requires active treatment.
- known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- have an active autoimmune disease requiring systemic treatment within the past 2 years.
- known history or any evidence of active noninfectious pneumonia.
- active infection requiring systemic therapy.
- 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.
- psychiatric or substance abuse disorders known to interfere with compliance with trial requirements.
- be pregnant or breastfeeding, or expect to become pregnant or give birth to a child within the intended duration of the trial.
- had a known history of human immunovirus (HIV) (HIV 1/2 antibodies).
- known to have active hepatitis B (e.g., HBsAg reactive) or hepatitis C.
- received live vaccine within 30 days of planned initiation of study treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06649838 · RCC-ctDNA