Radical Trachelectomy for Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00813007
First received: December 18, 2008
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

The goal of this research study is to learn about quality of life, sexual functioning, and symptoms in women who have undergone abdominal radical trachelectomy for cervical cancer.


Condition Intervention
Cervical Cancer
Behavioral: Questionnaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Radical Trachelectomy Outcomes in the Treatment of Early Stage Cervical Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean scores for the General Health-Related Quality of Life (SF-12) [ Time Frame: Follow up visits annually ] [ Designated as safety issue: No ]
    Completed SF-12 questionnaires at baseline and at each follow-up visit (4-6 weeks, 6 months, 1 year, and annually for 4 more years)


Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire
Radical trachelectomy outcomes for cervical cancer
Behavioral: Questionnaires
5 Questionnaires at differing times before and after surgery.
Other Name: Survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix.

Criteria

Inclusion Criteria:

  1. Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix.
  2. Patients with FIGO stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease.
  3. Patients must be suitable candidates for surgery.
  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 who are undergoing radical trachelectomy
  7. Women must be able to read and write in either Spanish or English

Exclusion Criteria:

  1. Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
  2. Tumor size greater than 4 cm
  3. FIGO stage II-IV disease
  4. Patients with a history of pelvic or abdominal radiotherapy
  5. Patients who are pregnant
  6. Patients with contraindications to surgery
  7. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813007

Contacts
Contact: Michael M. Frumovitz, MD 713-792-9599

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Michael M. Frumovitz, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michael M. Frumovitz, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00813007     History of Changes
Other Study ID Numbers: 2007-0723
Study First Received: December 18, 2008
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cervical Cancer
Cervix
Questionnaire
Adenocarcinoma of uterine cervix
Squamous cell carcinoma of uterine cervix
Adenosquamous carcinoma of uterine cervix
Abdominal radical trachelectomy
Trachelectomy
Quality of life
Sexual functioning

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

ClinicalTrials.gov processed this record on August 21, 2014