NCT03614689

Brief Summary

To analyze the proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations; the ctDNA characteristics in patients with ovarian cancer; the correlation between the clonal status of mutations and therapy response; whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence; and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
active not recruiting

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

Study Start

First participant enrolled

November 25, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

July 30, 2018

Last Update Submit

July 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The ctDNA characteristics in patients with ovarian cancer , the correlation between the clonal status of mutations and therapy response and whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence.

    2 years

Secondary Outcomes (1)

  • The proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer.

    1 years

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with previously untreated Ovarian Cancer.

You may qualify if:

  • Patients who have not received treatment including radiotherapy, chemotherapy, and surgery.
  • Expected to achieve satisfactory tumor cytoreductive surgery.
  • Estimated lifetime is more than 3 months.
  • Understand the research plan and voluntarily participate in the study, sign the informed consent form.
  • Ability to collect specimens from each time point and provide corresponding clinical information.

You may not qualify if:

  • Patients who will receive new adjuvant therapy.
  • Patients who have other primary cancer.
  • Pregnant or breast-feeding woman.
  • Patients with severe mental illness.
  • Patients achieve unsatisfactory tumor cytoreductive surgery.
  • Patients who voluntarily withdraw for any reason.
  • Patients who cannot complete the research plan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Peking University International Hospital

Beijing, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 3, 2018

Study Start

November 25, 2017

Primary Completion

November 30, 2020

Study Completion

December 1, 2024

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations