Viewing Study NCT06564428



Ignite Creation Date: 2024-10-26 @ 3:38 PM
Last Modification Date: 2024-10-26 @ 3:38 PM
Study NCT ID: NCT06564428
Status: RECRUITING
Last Update Posted: None
First Post: 2024-08-19

Brief Title: A Cohort Study of Genetic Ovarian Cancer Risk Prediction Models and Pathogenesis Exploration
Sponsor: None
Organization: None

Study Overview

Official Title: A Cohort Study of Genetic Ovarian Cancer Risk Prediction Models and Pathogenesis Exploration
Status: RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 pathogenicsuspected pathogenic mutations and to guide the intervention management of high-risk population of cancer

The study will identify novel tumor-causing mutationspredisposing genes by gene sequencing in a special family with hereditary tumor
Detailed Description: About 10-20 of ovarian cancers have familial aggregation suggesting that it may be hereditary ovarian cancer Exploring a genetic ovarian cancer risk prediction model suitable for Chinese people will help quantify the risk of cancer in high risk groups and guide preventive interventions The clinicopathology gene mutation and family history of hereditary ovarian cancer need to be deeply analyzed and the relevant research is still in the initial stage in China At the same time in a small number of ovarian cancer families with obvious familial aggregation genetic testing failed to detect known pathogenicpossible pathogenic mutations in the germ line suggesting that there may be a new pathogenic mechanism that needs further study

Based on the above clinical issues this project intends to establish a prospective multicenter cohort of hereditary ovarian cancer To describe the clinicopathological and genetic mutation characteristics of hereditary ovarian cancer patients in China and guide the individualized diagnosis and treatment of patients Through follow-up analysis of clinicopathological information gene mutation characteristics detailed family history and other factors a suitable ovarian cancer risk prediction model was established and preliminarily verified to guide the intervention management of high-risk groups Special genetic ovarian cancer families or early-onset ovarian cancer cases were collected and new tumor-causing mutationssusceptibility genes were explored through gene sequencing analysis and functional verification and preliminary mechanism studies were conducted

Relying on the National Clinical Research Center for Obstetrics and Gynecology the research team has been engaged in the clinical diagnosis treatment and scientific research of gynecological malignant tumors for a long time In China the gynecological tumor genetic consultation clinic was established earlier and there are mature platforms for diagnosis treatment and genetic blocking of hereditary ovarian cancer Our research group has initially established a genetic ovarian cancer cohort in our hospital which has included more than 1000 cases of patients with epithelial ovarian cancer and their families who have received surgical treatment in our hospital since 2016 In September 2022 it led the establishment of a multi-center gynecological tumor genetic diagnosis and treatment platform with 11 sub-centers across the country working together to focus on the diagnosis treatment and research of hereditary gynecological tumors

The development of this project will establish the ovarian cancer risk prediction model suitable for Chinese people for the first time and guide the prevention and intervention of high-risk groups Through special genetic ovarian cancer family mining to explore the new pathogenic mechanism of ovarian cancer to guide the early diagnosis of hereditary ovarian cancer At the same time it will promote the individualized and accurate diagnosis and treatment of hereditary ovarian cancer patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None