Clinical trial · Observational
Study to Determine the Feasibility of Sentinel Node Biopsy in Patients With Anal Cancer
R-SeNSAR Feasibility Study: The Role of Sentinel Node Biopsy in Patients With Anal Cancer
NCT02162641CI-TRIAL-00018124R-SeNSARwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated early as it failed to recruit.
Summary
Brief summary (as posted)
The purpose of this study is assess the technical and operational feasibility of a specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal cancer.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of the Anus | Anal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- SCC of the anus
- interventionNames
- Procedure: Sentinel lymph node biopsy
Primary outcomes (1)
- measure
- The proportion of nodes detected will be expressed per inguinal nodal basin and per number of patients
- timeFrame
- Day 0 (Day of SLNB)
Secondary outcomes (3)
- measure
- Micro-metastatic disease within sentinel nodes
- timeFrame
- Days 7 to 10
- measure
- Surgical complications
- timeFrame
- Up to 15 weeks after SLNB
- description
- To include wound healing assessment and assessment of pain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with squamous cell carcinoma (SCC) of the anus (any T size and/or those with recurrent disease) * Equivocal lymph node involvement on standard CT staging or magnetic resonance (MR) staging or PET-CT scan, as determined by the anal cancer multidisciplinary team (MDT) * Age \>= 18 years * Written informed consent provided by the patient Exclusion Criteria: * Patients with unequivocal lymph node involvement on standard CT staging or MR staging, as determined by the anal cancer MDT. * Unfit for surgical biopsy * Patients undergoing palliative treatment * Previous pelvic or inguinal area radiotherapy * Other coincident cancers * Previous inguinal surgery (e.g. hernia repair) with mesh insertion
References
Publications (0)
Data not yet available
No reference posted for this study.