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Survival Outcomes of Ovarian Malignancies in Chinese Population

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ClinicalTrials.gov Identifier: NCT03291262
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment
Ovarian Neoplasms Survival Other: Follow up for death and recurrence

Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Survival Outcomes of Ovarian Malignancies in Chinese Population
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Other: Follow up for death and recurrence
    Patients are followed up to determine the specific date of diagnosis, recurrence and death.


Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Periods from diagnosis of ovarian cancer to death

  2. Progression-free survival [ Time Frame: 5 years ]
    Periods from diagnosis of ovarian cancer or remission of disease to next recurrence



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with definite diagnosis of primary ovarian malignancies confirmed by pathologic examinations.
Criteria

Inclusion Criteria:

  • Primary ovarian malignancies.

Exclusion Criteria:

  • Metastatic malignancies to ovaries.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291262


Contacts
Contact: Lei Li, MD 13911988831 ext +86 lileigh@163.com

Locations
China, China/Beiing
Lei Li Recruiting
Beijing, China/Beiing, China, 100000
Contact: Lei L Li, MD    13911988831 ext +86    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
Principal Investigator: Lei Li, MD Peking Union Medical College Hospital

Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03291262     History of Changes
Other Study ID Numbers: SOOM-1
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders