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Genetic Mutation in Recurrent Cervical Cancer

Overall Perspective on the Characteristics of Genetic Mutation in Recurrent Cervical Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04191226
Enrollment
300
Registered
2019-12-09
Start date
2019-12-19
Completion date
2023-01-01
Last updated
2019-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copy Number Variation, Genomic Structural Variation, Insertion-deletion Variation, Microsatellite Instability, Nucleotide Variant, PD-1, PD-L1, Recurrent Cervical Cancer, Total Mutation Burden

Brief summary

Little is known about the characteristics of genetic mutation in recurrent cervical cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. The mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. The total mutation burden (TMB) will be calculated. The status of microsatellite instability, expression of PD-1 and PD-L1 antibodies are also tested. These findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy and immunotherapy.

Interventions

DIAGNOSTIC_TESTMulti-gene panel testing

A multi-gene panel, which consists of more than 500 hundred genes will be provided for mutation analysis

Sponsors

Lei Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18 years or older * Pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma * With available materials for analysis * With detailed clinicopathological information * Given consent to participate the trial

Exclusion criteria

* Not meeting all of the inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Frequency of genetic mutationsTwo yearsFrequency of various genetic mutations among recruited patients

Secondary

MeasureTime frameDescription
Total mutation burdenTwo yearsTotal mutation burden calculated in definite patient
Frequency of microsatellite InstabilityTwo yearsMicrosatellite Instability in definite patient
Expression rates of PD-1 and PD-L1 antibodiesTwo yearsExpression rates of PD-1 and PD-L1 antibodies among recruited patients

Countries

China

Contacts

Primary ContactLei Li
lileigh@163.com+8613911988831

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026