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

This study is currently recruiting participants.
Verified November 2016 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00791635
First Posted: November 14, 2008
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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 Intervention
Cervical Cancer Endometrial Cancer Vaginal Cancer Vulvar Cancer Gynecologic Cancer Behavioral: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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

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

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: November 13, 2008
First Posted: November 14, 2008
Last Update Posted: November 15, 2016
Last Verified: November 2016

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

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