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NCT Number: NCT06681259

Clinical Specialty Queue For Gestational Trophoblastic Neoplasia

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Weiguo Lv

Zhengjiang, Hangzhou, 310006, China

Location status: Recruiting

Location contact

Liu Min, postgraduate

CONTACT

[email protected]

0571-89998819

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    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.

    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.

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Collaborators

  • Qilu Hospital of Shandong University
  • Sun Yat-sen University
  • Tongji Hospital

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 8, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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