Genetic Mutation in Recurrent Cervical Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Microsatellite Instability; Recurrent Cervical Cancer; PD-L1; Nucleotide Variant; Copy Number Variation; Insertion-deletion Variation; Genomic Structural Variation; Total Mutation Burden; PD-1
• Intervention / Treatment: Diagnostic test: Multi-gene panel testing

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients of pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma, and aged 18 years or older

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of genetic mutations	Frequency of various genetic mutations among recruited patients	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total mutation burden	Total mutation burden calculated in definite patient	Two years
Frequency of microsatellite Instability	Microsatellite Instability in definite patient	Two years
Expression rates of PD-1 and PD-L1 antibodies	Expression rates of PD-1 and PD-L1 antibodies among recruited patients	Two years

Collaborators and Investigators

• Sponsor: Lei Li
• Investigators: Principal Investigator: Lei Li, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; Genomic Instability; Uterine Cervical Neoplasms; Recurrence; Microsatellite Instability
• Other Study ID Numbers: CC-TMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No