Study of Pomalidomide in Anal Cancer Precursors (SPACE): a Phase 2 Study of Immunomodulation in People With Persistent HPV-associated High Grade Squamous Intraepithelial Lesions
This is a single centre open label phase II trial to determine the antitumor efficacy of the oral immunomodulatory agent pomalidomide in persistent human papillomavirus (HPV) -associated high grade squamous intra-epithelial lesions (HSIL) in patients with and without human immunodeficiency virus (HIV) infection.
NCT03113942 — High Grade Squamous Intra-epithelial Lesion (HSIL)
Status: Active, not recruiting
http://inclinicaltrials.com/high-grade-squamous-intra-epithelial-lesion-hsil/NCT03113942/
A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer
The purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.
NCT03018418 — Anus Neoplasms
Status: Active, not recruiting
http://inclinicaltrials.com/anus-neoplasms/NCT03018418/
A Multicenter Phase 2 Clinical Trial of Pembrolizumab in Metastatic Anal Cancer
This research study is studying a targeted therapy as a possible treatment for advanced anal cancer. The following intervention will be involved in this study: -Pembrolizumab
NCT02919969 — Anal Cancer
Status: Completed
http://inclinicaltrials.com/anal-cancer/NCT02919969/
New Strategies to Assess Anal Cancer Risk In Women
The purpose of this research is to study different strategies to identify women at highest risk for anal cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk Index; it gives women an overall number score based on risk factors that they may have for anal cancer, such as age, number of sexual partners, or smoking. Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The study team will collect swabs of the cervix and the anus to study different laboratory tests that could identify women at highest risk of cervical and anal cancer. These laboratory tests include an anal pap smear, tests for markers of disease and tests that detect the HPV types most likely to cause cancer. The study team would like to see which of these laboratory tests do the best job at predicting precancerous lesions in the anus and are better indicators of risk for cancer. After collecting these swabs, women will have a procedure called high resolution anoscopy where investigators look closely at the anus and biopsy any suspicious areas. Finally, the study team will look for HPV proteins and changes that HPV can make in cells to see if these tests predict anal lesions.
NCT02873741 — Human Immunodeficiency Virus (HIV)
Status: Completed
http://inclinicaltrials.com/human-immunodeficiency-virus-hiv/NCT02873741/
Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level
The purpose of this study is to maximize patient involvement in the treatment of anal cancer. Specifically, the investigators will investigate whether patients wish to take part in the decision making on radiation dose and whether they want a high or low radiation dose.
NCT02785263 — Anal Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/anal-cancer/NCT02785263/
Individual Following in Anal Cancer With PET/CT
Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6% of anorectal cancers. Incidence is less than 1/100 000 of the general population. However, the incidence has increased considerably over the past three decades. The main risk factors are HPV infections and smoking. Initial treatment comprises radiochemotherapy or radiotherapy alone, according to the patient's tumor stage and tolerance of chemotherapy. The choice of the most appropriate treatment strategy will condition the patient's prognosis. Consequently, early assessment of the initial extension of the tumor, its therapeutic response and relapses constitute determining factors in the management of the disease Despite the good results obtained, persistent disease is observed in 30% of cases and abdominal-pelvic salvage amputation can then prove effective in cases of local or loco-regional relapse. The great majority of relapses occur within 2 years after treatment. Reported prognostic survival factors are the T stage, size inferior or superior to 4 cm and inguinal or pelvic lymph node involvement. The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses principally on the clinical examination although the type and frequency of the paraclinical examinations are not backed by any consensus.
NCT02697084 — Anal Cancer
Status: Recruiting
http://inclinicaltrials.com/anal-cancer/NCT02697084/
ANCA - A Registry Based Study of Clinical Results and Health Related Quality of Life in Patients After Treatment for Anal Cancer
A national study of a three year cohort consisting of all patients diagnosed with anal cancer in 2011- 2013 with data retrieval from three national registries: Cancer Registry, Patient registry and Cause of Death Registry all within the Swedish Board of Health and Welfare. All out- and inpatient visits with diagnoses, admission dates and discharge dates will be requested including. Patient documentation from the concerned hospitals will be collected and data on the details of the treatment collected retrospectively in a standardised fashion using a clinical record form. Comorbidity will be calculated using data from the Patient Registry using all main and co-diagnoses 2 years prior and then at least two years after treatment cessation. Detailed questionnaires will be sent out once at 2-3 years and a second time at about 6 years after index treatment.
NCT02546973 — Anal Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/anal-cancer/NCT02546973/
Prospective Validation Study Under CLIA-compliant SOPs for the Proprietary Rectal and Anal Cancer Protein Expression Assays
Patients with locally advanced rectal and esophageal carcinomas typically undergo neoadjuvant chemoradiation therapy prior to surgical resection. While response rates to this treatment differ among these three cancers, generally 20-25% of patients exhibit minimal or no response to preoperative chemoradiation therapy while 20-30% exhibit a complete pathologic response, and the remainder receiving a partial response. This will be a multi-center study of patients with newly diagnosed rectal adenocarcinoma, or anal squamous cell carcinoma (SCC) who will undergo neoadjuvant chemoradiation prior to surgery. The tumor from these patients will be tested to determine whether response to neoadjuvant chemoradiation can be accurately predicted.
NCT02407561 — Rectal Adenocarcinoma
Status: Terminated
http://inclinicaltrials.com/rectal-adenocarcinoma/NCT02407561/
R-SeNSAR Feasibility Study: The Role of Sentinel Node Biopsy in Patients With Anal Cancer
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.
NCT02162641 — Squamous Cell Carcinoma of the Anus
Status: Withdrawn
http://inclinicaltrials.com/squamous-cell-carcinoma-of-the-anus/NCT02162641/
The Natural History of Anal Human Papillomavirus Infection and Anal Cellular Abnormalities in Homosexual Men
SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of human papillomavirus (HPV). Some HPV types cause genital warts and other types cause more than 90% of anal cancer. Gay men are over 20 times more likely than others to develop anal cancer. SPANC is a study of anal (HPV) infection and related anal disease in gay men. The study will provide important information to guide the possible future introduction of anal cancer screening programs for gay men.
NCT02007421 — Cancer
Status: Completed
http://inclinicaltrials.com/cancer/NCT02007421/