Anal Cancer Clinical Trial
Official title:
The Role of Early Diagnosis and Treatment of Anal Intraepithelial Neoplasia in the Prevention of Anal Squamous Cell Carcinoma: Identifying Prognostic Biomarkers.
This is a study involving exome sequencing and immune profiling of matched tissue and blood samples from patients with both high-grade squamous intraepithelial lesions and anal squamous cell carcinoma. This is a collaborative project between Imperial College London and the Institute of Cancer Research (ICR), investigating the genetic predeterminants for the progression of anal HSIL to SCC as well as the immunogenetic profile of these conditions will be beneficial for risk stratification (with respect to identifying those individuals with anal HSIL most likely to progress to invasive disease), the identification of potential new drug targets and will add to our understanding of how the tumour microenvironment may influence treatment response and disease recurrence of both anal HSIL and SCC.
Patients, as identified by the colorectal MDT, are approached, and consented for tissue and blood collection on the day of their diagnostic procedure; the plasma and buffy coat are extracted from the EDTA tubes. A tissue biopsy is performed adjacent to the area sampled for diagnosis and flash frozen in liquid nitrogen. Once the diagnosis of anal cancer is confirmed, the FFPE diagnostic tissue, is requested from the Tissue Bank for the study. The FFPE and the fresh frozen tissue samples are sliced and put on slides. Stained slides are reviewed by a consultant histopathologist, areas of anal HSIL and SCC are marked. All samples are transferred to the ICR. Tumour DNA and RNA are extracted from the tissue samples and germline DNA from the buffy coat of the blood sample. Exome sequencing followed by Bioinformatic analysis is carried out where somatic mutations are evaluated for impact on gene expression and compared between germline, anal HSIL and SCC samples. After a quality control process is complete, the entire dataset is compared with the germline DNA reads, thereby identifying somatic mutations. Candidate mutations are finally cross-referenced with the Cancer Genome Census and string analysis of relevant mutations is performed to assess for cancerogenic impact. Bulk RNA and targeted RNA based T-Cell Receptor (TCR) sequencing will be carried out, with TCR sequencing also being performed on the blood. This will establish which immune cell types are present in the SCC vs HSIL (by transcriptomic deconvolution), and the repertoire of TCR in peripheral blood, HSIL and SCC. Multiplex immunofluorescence technology against distinct immune panels (established within the CTI), will further evaluate the SCC and HSIL immune microenvironments. The immune-data will be linked to clinical outcome (both radiological and clinical), following radical chemoradiation. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05060471 -
PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients
|
Phase 2 | |
| Active, not recruiting |
NCT02135419 -
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
|
Phase 3 | |
| Completed |
NCT05518201 -
Evaluate the Safety and Immunogenicity of a 9-valent HPV Vaccine in Chinese Healthy Male Aged 9-45 Year-old
|
Phase 1 | |
| Withdrawn |
NCT02857608 -
A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus
|
Phase 2 | |
| Active, not recruiting |
NCT02546973 -
Quality of Life in Patients With Anal Cancer
|
||
| Terminated |
NCT00903396 -
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
|
Phase 2 | |
| Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A | |
| Completed |
NCT00550589 -
Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus
|
Phase 2 | |
| Completed |
NCT00324415 -
Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
|
Phase 2 | |
| Terminated |
NCT00568425 -
QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT
|
||
| Terminated |
NCT00267787 -
Molecular Genetic and Pathological Studies of Anal Tumors
|
||
| Completed |
NCT00066430 -
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
|
Phase 1 | |
| Completed |
NCT04083053 -
High-Resolution Anoscopy Perceived Discomfort Study
|
N/A | |
| Completed |
NCT03506529 -
Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
|
||
| Recruiting |
NCT05835947 -
Anal Cancer Risk In Women
|
||
| Not yet recruiting |
NCT03947775 -
HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL
|
Phase 2 | |
| Recruiting |
NCT04857528 -
Detecting HPV DNA in Anal and Cervical Cancers
|
||
| Recruiting |
NCT04907643 -
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
|
N/A | |
| Recruiting |
NCT04708470 -
A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01937780 -
Anal Cancer Radiotherapy Study
|