A Cohort Study of Hereditary Ovarian Cancer Risk Prediction Models and Pathogenesis Exploration

NCT06564428 | Recruiting

• 1 other identifier: 000000
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to establish a bidirectional multicenter cohort of hereditary ovarian cancer and to describe the clinicopathologic features of hereditary ovarian cancer patients in our country. The risk prediction model of ovarian cancer for Chinese was established by following-up analysis of clinical and pathological information, genetic test results and detailed family history, to predict the risk of cancer in first-degree relatives of carriers of pathogenic/suspected pathogenic mutations, and to guide the intervention management of high-risk population of cancer. The study will identify novel tumor-causing mutations/predisposing genes by gene sequencing in a special family with hereditary tumor.

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

• The clinicopathological features and gene mutation characteristics of hereditary ovarian cancer

  * personal history (age, BMI, oral contraceptive use, hormone replacement therapy use, tubal ligation) * menstrual marriage and childbearing history (whether or not menopause, menopausal age, menarche age, the number of births) * personal history of tumor (history of malignant tumor, tumor type, pathological type, tumor stage, age of onset) ④family history of cancer (family history of cancer or not, number/person of cancer in first/second/third degree relatives, relationship with patients, tumor type, pathological type, tumor stage, age of onset, gene detection) ⑤results of gene detection (detection items, specimen type, mutation, mutated gene, cDNA change, amino acid change, mutation type, mutation significance)

  2024-2026

Secondary Outcomes (1)

• Newly diagnosed ovarian cancer in a first-degree relative

  2024-2026

Study Arms (2)

Mutation carriers

Patients presented to our hospital with a definite pathological diagnosis of epithelial ovarian cancer, who carry suspective gene mutations or have family history of cancer.

Genetic: Suspective gene mutations and family history

Control group

Patients presented to our hospital with a definite pathological diagnosis of epithelial ovarian cancer, who don't carry any suspective gene mutations and have no family history of any type of cancer.

Interventions

Suspective gene mutations and family history GENETIC

To observe if the patients with suspective gene mutations or family history take higher risk of suffering from ovarian cancer.

Mutation carriers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese female population of different regions and different ages.

You may qualify if:

• Epithelial ovarian cancer
• ≥18 years
• The pathological diagnosis was clear
• The genetic test showed germ line pathogenic/suspected pathogenic mutations (for mutation interpretation, refer to the American ACMG Classification Standards and Guidelines for Genetic Variation)

You may not qualify if:

• Non-epithelial ovarian cancer was confirmed by pathology
• No genetic test has been performed

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (19)

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Biospecimen

Retention: SAMPLES WITH DNA

blood sample for genetic testing

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Hongyan Guo, Doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Li, Doctor

CONTACT

18610689868; yuanli@bimu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-05

Locations

CN (1)