Uterine CancerNCT00706875
A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors
An observational study of Uterine Cancer and Cervix Uteri Nos, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Uterine Cancer, Cervix Uteri Nos, Gestational Trophoblastic Disease
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: GTD survivors treated at Memorial Sloan-Kettering Cancer Center (MSKCC).
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Being tested
- questionnaire
- Keywords
- GTD survivors, questionnaires, GTD
- Medical subject headings
- Uterine Neoplasms, Gestational Trophoblastic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
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
questionnaireBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | 30 patients survived GTD post treatment for 0 - 5 years. Receives: Behavioral: questionnaire | |
| 2 | 30 patients survived GTD post treatment 6 - 10+ years. Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: conclusion of the study
Secondary outcomes (1)
To describe the prevalence of premature menopause and increased bone loss through the Menopausal Symptom Check List and medical follow-up information.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Jewell, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706875
- Sponsor's protocol ID
- 08-040
- Status last verified
- Apr 2018
- First submitted
- 26 Jun 2008
- Last updated
- 30 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors
- ClinicalTrials.gov ID
- NCT00706875
- Acronym / sponsor ID
- 08-040
- Keywords
- GTD survivors, questionnaires, GTD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2008 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: questionnaire30 patients survived GTD post treatment for 0 - 5 years. |
| 2 | – | Behavioral: questionnaire30 patients survived GTD post treatment 6 - 10+ years. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- GTD survivors treated at Memorial Sloan-Kettering Cancer Center (MSKCC).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireA 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 | Behavioural | 1 |
| questionnaireA 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 | Behavioural | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Jewell, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cancer and Cervix Uteri Nos, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.