Immune Repertoire of Ovarian HGSC | NCT03794115

Studies
Immune Repertoire of Ovarian HGSC

NCT03794115

Sponsor

Lei Li

Status

Unknown status

Last Update Posted

Jan 4, 2019Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Ovarian High Grade Serous Carcinoma
Immune Repertoire
T Lymphocyte Receptor
B Lymphocyte Receptor

Interventions

Treatment for ovarian cancer

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

Jan 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

Jan 3, 2019Actual

Primary Completion Date

Jan 1, 2021Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Jan 3, 2019

First Submission Date that Met QC Criteria

Jan 3, 2019

First Posted Date

Jan 4, 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

Jan 3, 2019

Last Update Posted Date

Jan 4, 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

In this preliminary study, peripheral blood and carcinoma tissue with pericarcinomatous tissue are taken from the patients with ovarian high grade serous carcinoma at several points: before any treatment, after the debulking surgery, and after all the proposed chemotherapy. The differential expression of the T/B lymphocyte receptors in these samples will be analyzed with the platinum-based treatment and survival outcomes of the patients. The primary objective is the expression rates of T/B lymphocyte receptors in different stages of checking points.

Detailed Description

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

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment for ovarian cancer	Procedure	The treatment for ovarian cancer includes the debulking surgery and platinum-based chemotherapy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression rates of T lymphocyte receptors	Expression rates of T lymphocyte receptors in different stages of checking points, including timings before any treatment, after the debulking surgery, and after all the proposed chemotherapy	One year
Expression rates of B lymphocyte receptors	Expression rates of T lymphocyte receptors in different stages of checking points, including timings before any treatment, after the debulking surgery, and after all the proposed chemotherapy	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed of primary ovarian high grade serous carcinoma
Aged 18 years or older
No immunosuppressive disease
Signed an approved informed consents

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 confirmed of primary ovarian high grade serous carcinoma, aged 18 years or older and accept systematic treatment including debulking surgery and platinum-based chemotherapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided