A Randomized Phase II Study De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.
NCT04166318 — Anal Canal Cloacogenic Carcinoma
Status: Recruiting
http://inclinicaltrials.com/anal-canal-cloacogenic-carcinoma/NCT04166318/
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study
A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of <20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of >35-49% as Grade 3 and a reduction >/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.
NCT04094454 — Anal Cancer
Status: Recruiting
http://inclinicaltrials.com/anal-cancer/NCT04094454/
Determining the Accuracy of Self and Partner Anal Exams for Detecting Anal Abnormalities.
Anal cancer is a common cancer among men having sex with men (MSM). We will investigate increasing detection of anal canal tumors through self- or partner-palpation of the anal canal among MSM and trans persons. This study in Houston and Chicago will recruit a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged ≥ 25 years, who will be taught to perform an ASE or ACE. After performing the exam in private, the individual's ASE and partner's ACE will then be compared with a clinician's DARE. The assessment will be done at each of two visits, spaced 6-months apart. One-half of persons will be randomized to a practice condition to assess how practice affects accuracy and retention of exam procedure. Our hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits.
NCT04090060 — Anal Cancer
Status: Completed
http://inclinicaltrials.com/anal-cancer/NCT04090060/
SCAN-B-rec: Infrastructure, Technology Platform and Clinical Research Development to Profile and Monitor Metastatic Breast Cancer
Prospective multicenter observational study to assess molecular drivers of metastatic breast cancer and disease evolution upon therapeutic pressure. The main aim is to develop and validate prognostic, predictive and pathogenic markers in clinically well-characterized population-based material of breast cancer tumors and the corresponding normal tissue.These data will be used to characterize recurrent breast cancer on a molecular level, study tumor evolution, develop biomarkers of response/resistance to targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical studies and to elucidate mechanisms of resistance to therapy.
NCT03758976 — Metastatic Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/metastatic-breast-cancer/NCT03758976/
A Study to Screen for Anal Precancerous Squamous Intraepithelial Lesions and to Prevent Anal cancer in a Real-life Setting of People Living With HIV at Different Risk: the Seville HIV Anal Cohort
There is increasing awareness of augmenting risk of anal cancer in people living with HIV, especially among men who have sex with men (MSM). High resolution anoscopy (HRA) represents the gold standard to detect pre-cancerous anal high-grade squamous intraepithelial lesions (HSIL), however, the procedure is time-consuming, costly and, most importantly, the learning curve is very flat. This yields a poor implementation of anal screening and, likely, to an excess of otherwise preventable anal cancer. Other screening methods include digital ano-rectal examination, anal-rectal cytology and human papillomavirus (HPV) genotyping, since infection with high-risk HPV genotypes has been identified as the main reason for the development of HSIL. To date, there is no consensus in screening strategies. Furthermore, it remains unclear whether, in whom and to which extend the currently available topic and invasive treatment options for HSIL should be applied, given that the natural history of the development of anal cancer remains poorly understood. The present cohort study aims to provide real-life data on the screening, management and follow-up of HIV-infected MSM is warranted for a better understanding of anal cancer in this setting.
NCT03713229 — Anal Squamous Intraepithelial Neoplasia
Status: Enrolling by invitation
http://inclinicaltrials.com/anal-squamous-intraepithelial-neoplasia/NCT03713229/
Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer
The purpose of this research study is to find ways to screen for anal cancer among gay, bisexual, and other men who have sex with men (MSM) and transgender persons. This study will try to find out if persons will do annual anal cancer screening, what factors are associated with repeated screening, and how this affects a person's decision to have high-resolution anoscopy.
NCT03489707 — Anal Cancer
Status: Completed
http://inclinicaltrials.com/anal-cancer/NCT03489707/
The Molecular Fingerprint of Psychological Resilience - Implications for Diagnostic and Therapeutic Strategies
This study aims to define the association between psychological resilience and biomolecular signatures in cancer patients and to relate psychological resilience to prognosis, as this could potentially open up a novel avenue of therapeutic interventions, medical as well as psychosocial.
NCT03430492 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT03430492/
A Phase 1 Trial for Patients With Newly Diagnosed Anal Cancer Treated With Concurrent Radiation Therapy, 5FU, Mitomycin and BMX-001
In this Phase 1/2 study, the investigators will conduct a safety and efficacy study of the combination of BMX-001 with standard radiation therapy (RT) and concurrent 5-fluorouracil (5FU)/mitomycin in newly diagnosed Anal Squamous Cell Carcinoma (ASCC) patients. The primary objectives are: Phase 1 - is to determine the maximum tolerated dose (MTD) of BMX-001 in ASCC patients receiving RT and concurrent 5FU/mitomycin chemotherapy.2. For phase II part: To examine the impact of BMX-001 on the overall acute ≥ grade 3 toxicity rate of the normal tissue including rectum, bladder, and skin in combination with RT and concurrent 5FU/mitomycin in treatment of newly diagnosed ASCC patients
NCT03386500 — Radiation Exposure
Status: Recruiting
http://inclinicaltrials.com/radiation-exposure/NCT03386500/
Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.
NCT03381352 — Anal Cancer
Status: Recruiting
http://inclinicaltrials.com/anal-cancer/NCT03381352/
A Randomized Phase III Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer
This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
NCT03233711 — Anal Canal Cloacogenic Carcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/anal-canal-cloacogenic-carcinoma/NCT03233711/