Genetic Mutation in Recurrent Cervical Cancer | NCT04191226

Studies
Genetic Mutation in Recurrent Cervical Cancer

NCT04191226

Sponsor

Lei Li

Status

Unknown status

Last Update Posted

Dec 20, 2019Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

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

Interventions

Multi-gene panel testing

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2019Actual

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Dec 5, 2019

First Submission Date that Met QC Criteria

Dec 5, 2019

First Posted Date

Dec 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2019

Last Update Posted Date

Dec 20, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multi-gene panel testing	Diagnostic Test	A multi-gene panel, which consists of more than 500 hundred genes will be provided for mutation analysis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Li	Contact	+8613911988831		lileigh@163.com

Overall Officials

Name	Affiliation	Role
Lei Li	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lei Li	Recruiting	Beijing	Beijing Municipality	100730	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D053842	Microsatellite Instability

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

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