NCT07919431Enrolling by invitation
Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
A Prospective Study on the Application of Low-Depth Circulating Free DNA Fragmentomics in Monitoring Recurrence and Guiding Therapy for Cervical Cancer
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
This is a prospective, single-center, observational cohort study that plans to enroll 100 women aged 18 years or older with histologically confirmed cervical cancer who are scheduled to receive radical surgery, radiotherapy, or systemic therapy. The study aims to establish and validate a low-depth cfDNA fragmentomics approach-including tumor fraction, fragment length distribution, and copy number variation-together with cfHPV-DNA testing for monitoring recurrence risk and predicting treatment response. Serial blood samples (10 mL per collection) will be obtained before initial treatment, 1-4 weeks after standardized treatment, at 3 and 6 months, and every 3 months thereafter until 2 years after treatment completion or until an endpoint event; fresh or paraffin-embedded tumor tissue will also be collected for whole-exome sequencing and multi-omics analysis. The study will not alter participants' routine clinical treatment. Research-related risks are mainly blood draw-related discomfort, bleeding, or bruising; risks from standard radiotherapy, chemotherapy, or immunotherapy are part of routine clinical care and are not introduced by this observational study. Privacy and confidentiality risks will be minimized through informed consent, secure data storage, restricted database access, and confidential handling of records. cfDNA testing will be provided free of charge, and appropriate compensation may be provided based on participation and time commitment. The study is funded by 3D Medicines (Shanghai) Co., Ltd.; conflict-of-interest, data/sample-sharing, and intellectual property arrangements will be disclosed and managed according to institutional requirements.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 1 Nov 2026
- Start date
- 20 Jan 2026
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT07919431
What you commit to
- Study type: Observational
- Planned participants: 100
- From 20 Jan 2026 to the primary completion date, 30 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic therapy for cervical cancer (except neoadjuvant therapy).
Other illness
- A history of other malignancies (except cured tumors such as basal cell carcinoma of the skin).
- Severe hepatic or renal insufficiency, coagulation disorders, or active infection.
Other
- Pregnancy or breastfeeding.
- Inability to cooperate with follow-up or sample collection.
Who the study is looking for
- Female aged 18 years or older.
- Histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma, and other subtypes.
- Planned to receive radical treatment, including surgery, radiotherapy, or chemotherapy.
- Voluntarily agrees to participate and signs the informed consent form.
- Able to provide complete clinical and follow-up information for the study.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.