NCT03794115

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

January 3, 2019

Last Update Submit

January 3, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

The treatment for ovarian cancer includes the debulking surgery and platinum-based chemotherapy.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and carcinoma tissue with pericarcinomatous tissue are taken from the patients with ovarian high grade serous carcinoma

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

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

January 3, 2019

First Posted

January 4, 2019

Study Start

January 3, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations