Clinical trial · Interventional
Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer
Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy With Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (≤ 2CM) Cervical Cancer
- 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)
This clinical trial studies the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer. Studying quality-of-life in patients undergoing surgery for cervical cancer may help determine the intermediate-term and long-term effects of surgery.
Conditions
Conditions (7)
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 Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Lymphedema | — | UNRESOLVED | — |
| Stage IA1 Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IA2 Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IB1 Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conization | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
| Therapeutic Lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cone biopsy/lymphadenectomy or hysterectomy)
- description
- Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.
- interventionNames
- Procedure: Conization
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Therapeutic Conventional Surgery
- Procedure: Therapeutic Lymphadenectomy
Primary outcomes (4)
- measure
- Change in bladder and bowel function score based on supplemental bladder and bowel questions plus 4 items from the Functional Assessment of Cancer Therapy-Cervix (3 bladder and 1 bowel question)
- timeFrame
- Baseline to 3 years
- description
- Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must consent for the appropriate surgery * Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion \[LVSI\]+), IA2, and IB1 (tumor size \[maximum visible or palpable\]) =\< 2 cm), any grade * All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =\< 10 mm * Patients must have no evidence of metastasis on positron emission tomography (PET) scan or magnetic resonance imaging (MRI) or computed tomography (CT) scan of the pelvis and chest imaging * Patients who have met the pre-entry requirements * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 Exclusion Criteria: * Patients with stage IA1 disease who are LVSI negative * Patients with stage IB1 with tumor size (maximum visible or palpable) \> 2 cm * Patients with \>= stage IB2 disease * Patients with clear cell or neuroendocrine cell types * Patients with depth of invasion \> 10 mm on first cone biopsy (or LEEP) * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
References
Publications (1)
- DERIVEDBoisen M, Guido R. Emerging Treatment Options for Cervical Dysplasia and Early Cervical Cancer. Clin Obstet Gynecol. 2023 Sep 1;66(3):500-515. doi: 10.1097/GRF.0000000000000790. Epub 2023 Jul 25. PMID 37650664