Clinical trial · Observational
Radical Trachelectomy for Women With Early Stage Cervical Cancer
NCT00813007CI-TRIAL-00042962unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. This is an investigational study. Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Questionnaire
- description
- Radical trachelectomy outcomes for cervical cancer
- interventionNames
- Behavioral: Questionnaires
Primary outcomes (1)
- measure
- Mean scores for the General Health-Related Quality of Life (SF-12)
- timeFrame
- Follow up visits annually
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.