Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer

NCT05602831 | Unknown

• 1 other identifier: LACC-BD-1
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is conducted to assess the value of using peripheral blood ctDNA to detect dynamic changes in HPV and genetic variants in predicting the prognosis of patients with locally advanced cervical cancer, as compared with traditional imaging and tumor markers.

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Assess PFS in ctDNA HPV and genetic variants clearance versus not clearance

  Two years

Secondary Outcomes (2)

• Overall Survival (OS)

  Two years

• Recurrence prediction performance of ctDNA dynamic changes

  Two years

Study Arms (2)

operable treatment group

After enrollment, patients will receive standard treatment and conventional follow-up strategy. Peripheral blood samples will be collected before treatment and at different time points after starting treatment. Baseline surgical tissue will be also obtained.

Other: detect HPV and genetic variants

radical chemoradiotherapy group

After enrollment, patients will receive standard treatment and conventional follow-up strategy. Peripheral blood samples will be collected before treatment and at different time points after starting treatment. Baseline puncture tissue will be also obtained before radical chemoradiotherapy.

Other: detect HPV and genetic variants

Interventions

detect HPV and genetic variants OTHER

Serum tumor markers and ctDNA HPV and genetic variants will be detected in peripheral blood samples. HPV and genetic variants will be also detected in baseline surgical tissues.

operable treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort A：Patients with initial diagnosis, operable locally advanced cervical cancer, FIGO stage IB2/3-IIA1/2. Cohort B：Patients with initial diagnosis, receive radical chemoradiotherapy locally advanced cervical cancer, FIGO stage IIB-IVA.

You may qualify if:

• Patients with initial diagnosis, operable locally advanced cervical cancer, FIGO stage IB2/3-IIA1/2 or initial diagnosis, receive radical chemoradiotherapy locally advanced cervical cancer, FIGO stage IIB-IVA
• Not receiving systemic treatment
• Pathological diagnosis: cervical squamous cell carcinoma
• Aged 18-70 years
• ECOG PS: 0-1
• Patients volunteer to participate in this study and sign the informed consent, with good compliance, and cooperate with the acquisition of tissue samples and blood samples

You may not qualify if:

• Patients diagnosed with other malignancies within 5 years
• Patients had received previous systemic antitumor therapy
• In the judgment of the investigator, the patients had other factors that might have caused the study to be discontinued

Sponsors & Collaborators

• Fudan University: lead
• Amoy Diagnostics: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200023, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue and peripheral blood

Central Study Contacts

Hao Wen, MD

CONTACT

+86-021-64175590; wenhao@shca.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecologic Oncology

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: August 10, 2022
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)