A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors

The purpose of this study is to collect information on the effects of treatment for gestational trophoblastic disease (GTD). We plan to use the findings from this study to better understand GTD survivors' health and quality of life.

We would like to know more about the health, quality of life and pregnancies of women treated for GTD. This information will be used to try and improve the treatments for women who have this disease.

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Key information

Conditions

Uterine Cancer CERVIX UTERI NOS Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gestational Trophoblastic Disease Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Pregnancy Complications Pregnancy Complications, Neoplastic Trophoblastic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Pathology confirmed GTD by MSKCC
Sufficient proficiency in the English language to respond to quality of life surveys
Age ≥ 18 years
Benign or malignant disease
Treated with surgery and/or chemotherapy or observation

Exclusion criteria

None

Treatment and study plan

Questionnaire

Behavioral

A patient questionnaire, which includes validated instruments. Data collection methods are as follows:

In person at the medical appointment
Over the telephone
Mailed with self-addressed return envelope and prepaid postage
E-mailed and returned by e-mail, fax or self-addressed envelope and pre-paid postage

Primary outcomes

The primary outcomes include reproductive concerns (as measured by the Reproductive Concern Scale, RCS) and sexual functioning (as measured by the Female Sexual Function Index, FSFI).

Time frame: conclusion of the study

Secondary outcomes

To describe the prevalence of premature menopause and increased bone loss through the Menopausal Symptom Check List and medical follow-up information.

Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2018
Study completion: 2018
First posted: Jun 30, 2008
Registry last updated: Apr 30, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed