- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00706875
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
|
A patient questionnaire, which includes validated instruments. Data collection methods are as follows:
|
2
30 patients survived GTD post treatment 6 - 10+ years.
|
A patient questionnaire, which includes validated instruments. Data collection methods are as follows:
|
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
Investigators
- Principal Investigator: Elizabeth Jewell, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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