Genetic Mutation in Recurrent Cervical Cancer

Recurrent Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191226
• Other study ID #: CC-TMB
• Status: Recruiting
• Start date: December 19, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: December 2019
• Source: Peking Union Medical College Hospital
• Contact: Lei Li
• Phone: +8613911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Multi-gene panel testing
A multi-gene panel, which consists of more than 500 hundred genes will be provided for mutation analysis

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of genetic mutations	Frequency of various genetic mutations among recruited patients	Two years
Secondary	Total mutation burden	Total mutation burden calculated in definite patient	Two years
Secondary	Frequency of microsatellite Instability	Microsatellite Instability in definite patient	Two years
Secondary	Expression rates of PD-1 and PD-L1 antibodies	Expression rates of PD-1 and PD-L1 antibodies among recruited patients	Two years