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Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy

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ClinicalTrials.gov Identifier: NCT00791635
Recruitment Status : Recruiting
First Posted : November 14, 2008
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this study is to learn if certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from pelvic exenteration surgery. Researchers will compare the types of surgery completed and procedures used to find out which are most effective and safe. Researchers will also study how the surgery affected your quality of life.

Condition or disease Intervention/treatment
Cervical Cancer Endometrial Cancer Vaginal Cancer Vulvar Cancer Gynecologic Cancer Behavioral: Questionnaires

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy
Study Start Date : September 2008
Estimated Primary Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Prospective Group
Questionnaires Prior to Scheduled Pelvic Exenteration Surgery.
Behavioral: Questionnaires
11 Questionnaires
Other Name: Survey
Retrospective Group
Questionnaires Post Pelvic Exenteration Surgery.
Behavioral: Questionnaires
11 Questionnaires
Other Name: Survey


Outcome Measures

Primary Outcome Measures :
  1. Types of Complications Experienced by Women Undergoing Pelvic Exenteration [ Time Frame: 4 Years ]

Secondary Outcome Measures :
  1. Number of complications experienced by women who undergo pelvic exenteration by vaginal and bladder reconstruction types [ Time Frame: 4 Years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women having gynecological cancer that was either treated with or will be treated with pelvic exenteration surgery.
Criteria

Inclusion Criteria:

  1. Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology.
  2. Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy.
  3. Patients must be suitable candidates fo surgery (in case of prospective collection).
  4. Patients who have signed an approved Informed Consent.
  5. Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease.
  6. Females older than 18 years.
  7. Women must be able to read and write in either Spanish or English.

Exclusion Criteria:

  1. Patients with contraindications to surgery.
  2. Patients unwilling or unable to complete self-administered questionnaires.
  3. Patients who do not read or speak English or Spanish.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791635


Contacts
Contact: Pamela Soliman, MD 713-745-2352

Locations
United States, Texas
Memorial City Recruiting
Houston, Texas, United States, 77024
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Pamela Soliman, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Pamela Soliman, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00791635     History of Changes
Other Study ID Numbers: 2008-0095
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by M.D. Anderson Cancer Center:
Vaginal Cancer
Cervical Cancer
Endometrial Cancer
Cervix
Endometrial
Pelvic Exenteration
Pelvic Exenteration Surgery
Questionnaire
Gynecologic Cancer
Vagina
Vulva
Gynecologic Malignancy

Additional relevant MeSH terms:
Vaginal Neoplasms
Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vulvar Diseases
Vaginal Diseases