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Radical Trachelectomy for Women With Early Stage Cervical Cancer
This study is currently recruiting participants.
Verified November 2016 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00813007
First received: December 18, 2008
Last updated: November 9, 2016
Last verified: November 2016
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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 for Women With 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 ]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 2018 (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 (Adult) |
| Sexes 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:
- Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix.
- Patients with FIGO stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease.
- Patients must be suitable candidates for surgery.
- Patients who have signed an approved Informed Consent
- Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease
- Females older than 18 years who are undergoing radical trachelectomy
- Women must be able to read and write in either Spanish or English
Exclusion Criteria:
- Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- Tumor size greater than 4 cm
- FIGO stage II-IV disease
- Patients with a history of pelvic or abdominal radiotherapy
- Patients who are pregnant
- Patients with contraindications to surgery
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813007
Contacts
| Contact: Michael M. Frumovitz, MD | 713-792-9599 |
Locations
| United States, Texas | |
| University of Texas 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:
| 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: | November 9, 2016 |
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 July 17, 2017