Genetic Mutation in Recurrent Cervical Cancer

NCT04191226 | Unknown

• 1 other identifier: CC-TMB
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Frequency of genetic mutations

  Frequency of various genetic mutations among recruited patients

  Two years

Secondary Outcomes (3)

• Total mutation burden

  Two years

• Frequency of microsatellite Instability

  Two years

• Expression rates of PD-1 and PD-L1 antibodies

  Two years

Interventions

Multi-gene panel testing DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and paired tumor tissues

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Microsatellite Instability

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lei Li

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li

CONTACT

+8613911988831; lileigh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: December 19, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

CN (1)