Genetic Mutation in Recurrent Cervical Cancer

• Sponsor: Lei Li (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04191226
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 36.4
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Cervical Cancer; Nucleotide Variant; Copy Number Variation; Insertion-deletion Variation; Genomic Structural Variation; Total Mutation Burden; Microsatellite Instability; PD-1; PD-L1	Diagnostic Test: Multi-gene panel testing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Overall Perspective on the Characteristics of Genetic Mutation in Recurrent Cervical Cancer
• Actual Study Start Date: Dec 19, 2019
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Outcome Measures

Primary Outcome Measures

1. Frequency of genetic mutations [Two years]

   Frequency of various genetic mutations among recruited patients

Secondary Outcome Measures

1. Total mutation burden [Two years]

   Total mutation burden calculated in definite patient

2. Frequency of microsatellite Instability [Two years]

   Microsatellite Instability in definite patient

3. Expression rates of PD-1 and PD-L1 antibodies [Two years]

   Expression rates of PD-1 and PD-L1 antibodies among recruited patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lei Li	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Lei Li

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT04191226
• Other Study ID Numbers: CC-TMB
• First Posted: Dec 9, 2019
• Last Update Posted: Dec 20, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Recurrence; Microsatellite Instability

Study Results

No Results Posted as of Dec 20, 2019