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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

A total of 60 patients with cervical cancer were enrolled, including 10 patients with local advanced cervical cancer (IB3-IIB) and 20 patients with advanced cervical cancer (10 patients with stage IIIC and 10 patients with stage IV). The second team consisted of 30 patients with recurrent cervical cancer.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Somatic mutation detection by WES

Time frame
from Des 2024 to Oct 2026

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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