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

NCT ID: NCT00706875

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Cancer Cervix Uteri Nos Gestational Trophoblastic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

30 patients survived GTD post treatment for 0 - 5 years.

questionnaire

Intervention Type 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

2

30 patients survived GTD post treatment 6 - 10+ years.

questionnaire

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Jewell, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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08-040

Identifier Type: -

Identifier Source: org_study_id

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