Clinical Specialty Queue For Gestational Trophoblastic Neoplasia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Collaborate with multiple tertiary hospitals nationwide to collect ethical approvals for gynecological oncology clinical trials and include them in the group Information on GTN patients who received treatment at participating units within the next 5 years.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Collect disease-related clinical and pathological features of the included subjects

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 on the diagnosis, treatment plan, levels of human chorionic gonadotropin, and toxic side effects of patients during the diagnosis and treatment period.

Time frame
GTN should be closely followed up after treatment, with monthly follow-up once in the first year and 2-3 days Follow up once every 3 months annually for a total of 5 years.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Women's Hospital School Of Medicine Zhejiang University

Lead sponsor

Tongji Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

Sun Yat-sen University

Collaborator