Clinical trial · Interventional
Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.
Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients With Sentinel Lymph Nodes Determined to be Negative for Metastatic Disease.
- 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 purpose of this study is to evaluate a less invasive procedure for the evaluation of the inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva. Each patient will undergo a sentinel lymph node dissection as well as resection of the primary tumor on the vulva. Patients who are determined to have sentinel nodes that are negative for metastatic disease will not receive a full groin dissection. Patients who have sentinel lymph nodes that contain metastasis will undergo a complete inguinal dissection. The study will evaluate the long-term outcomes in patients who receive only a sentinel lymph node dissection without a complete dissection. All patients entered onto the study will have a biopsy proven squamous cell carcinoma of the vulva. Each patient will be enrolled by a Gynecologic Oncologist practicing out of Women \& Infants Hospital
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 |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel Node Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- No intervention
- description
- Patients with negative SLN will be followed on no intervention arm
- interventionNames
- Procedure: Sentinel Node Biopsy
Primary outcomes (1)
- measure
- Determination of inguinal recurrence rates in patients with negative sentinel lymph node biopsy alone.
- timeFrame
- Three years
Secondary outcomes (1)
- measure
- Ability to detect inguinal sentinel nodes in vulvar cancer patients.
- timeFrame
- Three years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient of any age 18 years or over. 2. Biopsy proven squamous cell carcinoma of the vulva. 3. Depth of invasion 1mm or greater. 4. Patients with groins clinically negative for nodal metastasis. 5. Patients that are candidates for groin dissections. Exclusion Criteria: 1. Any patient below the age of 18 2. Patients with clinically suspicious groin nodes for metastatic disease. 3. Patients with non-squamous cell vulvar lesions. 4. Depth of invasion less than 1mm. 5. Patients refusing to sign an informed consent form.
References
Publications (24)
- BACKGROUNDJemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26. doi: 10.3322/canjclin.53.1.5. PMID 12568441
- BACKGROUNDJemal A, Murray T, Ward E, Samuels A, Tiwari RC, Ghafoor A, Feuer EJ, Thun MJ. Cancer statistics, 2005. CA Cancer J Clin. 2005 Jan-Feb;55(1):10-30. doi: 10.3322/canjclin.55.1.10. PMID 15661684
- BACKGROUNDPodratz KC, Symmonds RE, Taylor WF, Williams TJ. Carcinoma of the vulva: analysis of treatment and survival. Obstet Gynecol. 1983 Jan;61(1):63-74. PMID 6823350
- BACKGROUNDHacker NF, Leuchter RS, Berek JS, Castaldo TW, Lagasse LD. Radical vulvectomy and bilateral inguinal lymphadenectomy through separate groin incisions. Obstet Gynecol. 1981 Nov;58(5):574-9. PMID 7301232
- BACKGROUNDCabanas RM. An approach for the treatment of penile carcinoma. Cancer. 1977 Feb;39(2):456-66. doi: 10.1002/1097-0142(197702)39:23.0.co;2-i. PMID 837331
- BACKGROUNDMorton DL, Wen DR, Wong JH, Economou JS, Cagle LA, Storm FK, Foshag LJ, Cochran AJ. Technical details of intraoperative lymphatic mapping for early stage melanoma. Arch Surg. 1992 Apr;127(4):392-9. doi: 10.1001/archsurg.1992.01420040034005. PMID 1558490
- BACKGROUNDLevenback C, Burke TW, Morris M, Malpica A, Lucas KR, Gershenson DM. Potential applications of intraoperative lymphatic mapping in vulvar cancer. Gynecol Oncol. 1995 Nov;59(2):216-20. doi: 10.1006/gyno.1995.0011. PMID 7590476
- BACKGROUNDLevenback C, Morris M, Burke TW, Gershenson DM, Wolf JK, Wharton JT. Groin dissection practices among gynecologic oncologists treating early vulvar cancer. Gynecol Oncol. 1996 Jul;62(1):73-7. doi: 10.1006/gyno.1996.0192.