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Trial Title:
Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer
NCT ID:
NCT05602831
Condition:
Locally Advanced Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
detect HPV and genetic variants
Description:
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.
Arm group label:
operable treatment group
Intervention type:
Other
Intervention name:
detect HPV and genetic variants
Description:
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 puncture
tissues.
Arm group label:
radical chemoradiotherapy group
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200023
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Wen, MD
Phone:
+862164175590
Phone ext:
81000
Email:
wenhao@shca.org.cn
Start date:
August 10, 2022
Completion date:
August 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Amoy Diagnostics Co., LTD
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05602831
