The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorGeneplus-Beijing Co. Ltd.

About this trial

This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) Confirmed by histopathology and classified as stage IB-IVA cervical cancer patients according to the 2018 FIGO staging criteria;

Disqualifiers

1) Within 5 years, suffering from other malignant tumors or metastatic or recurrent cervical cancer;

Trial population

This study focuses on newly diagnosed cervical cancer patients who have been confirmed by histology or cytology to undergo surgical resection or curative radiotherapy and chemotherapy in locally advanced stages (stages IB-IV). A total of 80 patients who meet the inclusion criteria and voluntarily sign informed consent forms are planned to be enrolled. According to the curative treatment measures that patients can accept, the enrolled patients are divided into a operable treatment queue (N=40) and a curative radiotherapy and chemotherapy treatment queue (N=40).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Surgical treatment queue (N=40)
Group B: Radical radiotherapy and chemotherapy treatment cohort (N=40)

Trial outcomes

Primary outcomes

1

DFS of enrolled patients for 2 years

DFS of enrolled patients for 2 years

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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