Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer
NCT ID: NCT05531981
Last Updated: 2022-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
350 participants
OBSERVATIONAL
2022-09-20
2025-09-01
Brief Summary
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Detailed Description
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After the patients were enrolled in the study according to the criteria, they were given standard treatment. The patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, HPV typing test, SCC, CA125, and imaging examination such as CT or MRI if necessary.
Peripheral blood samples were collected to detect HPV E7 ctDNA before treatment, after treatment, and at 6, 12, 18, 24, 30, and 36 months of follow-up.
The primary endpoint is Disease-free survival (DFS, time from the treatment initiation to disease progression). Secondary endpoints include HPV ctDNA state before treatment, dynamic change trend of HPV ctDNA after treatment and overall survival (OS, time from the treatment initiation to death).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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initial surgical treatment group
After the patients were enrolled in the study according to the criteria, they were given standard treatment. The patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, HPV typing test, SCC, CA125, and imaging examination such as CT or MRI if necessary.
Peripheral blood samples were collected to detect HPV E7 ctDNA before treatment, 2 weeks after surgery, (1 month after adjuvent radiotherapy if available) and at 6, 12, 18, 24, 30, and 36 months of follow-up.
detect HPV E7 ctDNA
Peripheral blood was collected from the patients, and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR
initial concurrent chemoradiotherapy group
After the patients were enrolled in the study according to the criteria, they were given standard treatment. The patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, HPV typing test, SCC, CA125, and imaging examination such as CT or MRI if necessary.
Peripheral blood samples were collected to detect HPV E7 ctDNA before treatment, 1 month after radiotherapy and at 6, 12, 18, 24, 30, and 36 months of follow-up.
detect HPV E7 ctDNA
Peripheral blood was collected from the patients, and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR
Interventions
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detect HPV E7 ctDNA
Peripheral blood was collected from the patients, and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR
Eligibility Criteria
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Inclusion Criteria
* FIGO stage: IA2-IVA
* HPV typing: type 16 or 18
* ECOG 2-0
* The initial treatment was surgery (Cohort A) / concurrent chemoradiotherapy (Cohort B)
Exclusion Criteria
* Pregnant or lactating women
* Refused to sign a consent form
18 Years
FEMALE
No
Sponsors
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Beijing Obstetrics and Gynecology Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Precision Scientific (Beijing) Co., Ltd
UNKNOWN
Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CC-MRD-1
Identifier Type: -
Identifier Source: org_study_id
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