NCT03291262

Brief Summary

This study aims to determine survival outcomes (overall survival and progression-free survival) of primary ovarian malignancies in China and relevant risk factors in a prospective cohort study.

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

5 years

First QC Date

September 20, 2017

Last Update Submit

November 9, 2018

Conditions

Ovarian NeoplasmsSurvival

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    Periods from diagnosis of ovarian cancer to death

    5 years

  • Progression-free survival

    Periods from diagnosis of ovarian cancer or remission of disease to next recurrence

    5 years

Interventions

Follow up for death and recurrenceOTHER

Patients are followed up to determine the specific date of diagnosis, recurrence and death.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with definite diagnosis of primary ovarian malignancies confirmed by pathologic examinations.

You may qualify if:

  • Primary ovarian malignancies.

You may not qualify if:

  • Metastatic malignancies to ovaries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, China/Beiing, 100000, China

RECRUITING

Related Publications (1)

  • Sun T, Li L. A cohort study of hypersensitivity reaction in patients with epithelial ovarian cancer treated with carboplatin. Int J Gynecol Cancer. 2019 Mar;29(3):566-571. doi: 10.1136/ijgc-2018-000072. Epub 2018 Dec 22.

    PMID: 30833442DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Death Domain

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

Intervention Hierarchy (Ancestors)

Death Domain SuperfamilyProtein Interaction Domains and MotifsProtein DomainsProtein Structural ElementsProtein ConformationMolecular ConformationMolecular StructureBiochemical PhenomenaChemical Phenomena

Study Officials

  • Lei Li, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, MD

CONTACT

13911988831lileigh@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 25, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

CN(1)