Clinical Specialty Queue For Gestational Trophoblastic Neoplasia

NCT ID: NCT06681259

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-04

Study Completion Date

2029-11-04

Brief Summary

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The aim of this study is to establish a bidirectional cohort study of GTN specific diseases, including 1020 retrospective cases Queue and 1000 prospective cohorts. Based on the clinical collaboration system for gynecological tumors in multiple tertiary hospitals across the country, establish unified criteria for case inclusion and exclusion, and establish a multi center clinical queue for GTN; Collect baseline information of GTN patients, such as age, reproductive history, environmental and social information, genetic related information, physical examination, physicochemical, imaging, and pathological information; Collect biological specimens such as blood/tissue from patients; Collect information related to the diagnosis, treatment plan, human chorionic gonadotropin (hCG) levels, and toxic side effects of patients during the diagnosis and treatment period; After the end of treatment, follow-up blood hCG levels, imaging, fertility status, as well as recurrence and metastasis status, are conducted to track prognosis, thus building a clinical diagnosis and treatment information database, forming a standardized follow-up system for GTN, identifying high-risk factors for GTN chemotherapy resistance, constructing a precise evaluation model for GTN resistance, and providing high-level evidence-based medicine for effectively improving the initial treatment efficacy of GTN.

Detailed Description

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Conditions

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Gestational Trophoblastic Neoplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ① Age ≥ 18 years old; ② Patients clinically diagnosed with GTN (including invasive cases) Molar pregnancy, choriocarcinoma, PSTT, ETT); ③ Complete informed consent for enrollment.

Exclusion Criteria

* ① Having mental illness or cognitive impairment, unable to cooperate in completing the investigation with Patients with concurrent malignant tumors; ③ Participants with severe missing follow-up data.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Weiguo Lv

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Weiguo Lv

Zhengjiang, Hangzhou, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Liu Min, postgraduate

Role: primary

0571-89998819

Other Identifiers

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IRB-20240344-R

Identifier Type: -

Identifier Source: org_study_id

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