Clinical trial NCT05602831: Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer
Official title: Using Peripheral Blood Circulating Tumor DNA (ctDNA) Based Human Papillomavirus (HPV) and Genetic Variant Test to Assess the Prognosis of Surgery or Radical Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Locally Advanced Cervical Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Amoy Diagnostics
First posted: 2022-11-02
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The goal of this study is to assess the prognostic value of ctDNA HPV and gene variant clearance in peripheral blood.

Two cohorts will be enrolled: operable group and radical chemoradiotherapy group.

After enrollment, patients will receive standard treatment and follow-up strategy. Peripheral blood samples will be collected from 2 cohorts of patients before treatment and at different time points after starting treatment. Baseline surgical or puncture tissues will be also obtained.

Peripheral blood ctDNA and baseline tissues will be tested for HPV copy number based on ddPCR and genetic variation based on next-generation sequencing (NGS).

Finally, the correlation of ctDNA HPV and genetic variation clearance with patients prognosis and its value for recurrence monitoring compared to traditional tumor markers and imaging examination will be analyzed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Two years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Two years
measure: Recurrence prediction performance of ctDNA dynamic changes
timeFrame: Two years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: