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

April 27, 2018 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

GTD survivors treated at Memorial Sloan-Kettering Cancer Center (MSKCC).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
30 patients survived GTD post treatment for 0 - 5 years.
Behavioral: questionnaire

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
2
30 patients survived GTD post treatment 6 - 10+ years.
Behavioral: questionnaire

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Elizabeth Jewell, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2008

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria

June 27, 2008

First Posted (Estimate)

June 30, 2008

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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