Trial record 17 of 25 for:    Open Studies | "Vulvar Neoplasms"

Pelvic Exenteration for Gynecologic Malignancy

This study is currently recruiting participants.
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00791635
First received: November 13, 2008
Last updated: March 19, 2014
Last verified: March 2014
  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 this surgery affects 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Primary Completion Date: September 2016 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791635

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

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00791635     History of Changes
Other Study ID Numbers: 2008-0095
Study First Received: November 13, 2008
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 23, 2014