Screening HIV-Infected Women for Anal Cancer Precursors
This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may help doctors find cancer cells early and plan better treatment for anal cancer. Completing multiple screening tests may help find the best method for detecting cell changes in the anus.
NCT01946139 — HIV Infection
Status: Completed
http://inclinicaltrials.com/hiv-infection/NCT01946139/
Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship
This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. A structured intervention program for management of late effects will be evaluated. Symptom relief of palliative radiotherapy will be investigated. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.
NCT01937780 — Anal Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/anal-cancer/NCT01937780/
Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus
Anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. This is very successful (75% long term survival). During the course of the radiotherapy, other organs in the pelvis may be damaged. This can lead to long-term problems with possible changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain during sexual intercourse with vaginal dryness and shrinkage. Patients should be offered help with these side effects. At present, there is very little information on the effect treatment has on a patient's quality of life, making it difficult to judge if new treatment methods are better. This project will measure quality of life from the patient's perspective after treatment for anal cancer. It will also gather preliminary data on quality of life after the introduction of a new technique for more precise 3D-targeting of radiotherapy beams at the cancer, called IMRT.
NCT01853059 — Anal Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/anal-cancer/NCT01853059/
Predictive Modeling of Anal Dysplasia Progression in HIV
The purpose of this study is to determine whether a model can be created to predict the progression of early anal cancer precursor lesions in HIV using potential predictors such as: HIV treatment history, smoking history, sexual history, human papillomavirus viral load, human papillomavirus protein expression, and cell markers associated with progression of HPV-related lesions.
NCT01709448 — Papillomavirus Infections
Status: Recruiting
http://inclinicaltrials.com/papillomavirus-infections/NCT01709448/
1997-2011 Duodenal Cancer Analysis in Southern Denmark
To see how a cohorte of 55 patients over periode 1997-2011 were mannaged, treated and survived duodenal cancer. Also to see how advanced the tumors were at time of diagnose and at time of operation.
NCT01661049 — Duodenal Cancer
Status: Completed
http://inclinicaltrials.com/duodenal-cancer/NCT01661049/
A Pilot Trial Assessing the Feasibility of Delivering Topical MTS-01 to Reduce Dermatitis in Patients Receiving Intensity Modulated Radiation With Concurrent 5-Fluorouracil and Mitomycin-C for Stage I-III Carcinoma of the Anal CAnal
Background: - Radiation and chemotherapy treatments for anal cancer can cause irritation of the skin that can lead to redness and tenderness, and in some cases can be so severe that it results in blistering or peeling of the skin during treatment. These conditions cause discomfort and may require breaks from radiation treatment. Researchers are interested in determining whether MTS-01, a drug that protects cells and tissues from the effects of radiation, can be given before radiation treatment to prevent these side effects and reduce the irritation of the skin during chemotherapy and radiation for anal cancer. Objectives: - To determine the safety and effectiveness of topical MTS-01 given before radiation in the groin and gluteal cleft of patients receiving combined radiation and chemotherapy for anal cancer. Eligibility: - Individuals at least 18 years of age who have been diagnosed with cancer of the anal canal and are eligible to receive radiation and chemotherapy treatments. Design: - Participants will be screened with a physical examination, medical history, blood tests, imaging studies and physical examination of the anal canal, and biopsies as needed to evaluate eligibility for treatment. - Participants will be scheduled for radiation and chemotherapy treatments on the following schedule: - Radiation given 5 days per week for 6 weeks, with topical MTS-01 treatment on the skin in the groin areas and between the buttocks before each treatment - Mitomycin C given intravenously on days 1 and 29 of treatment - 5-Fluorouracil given intravenously over 4 days (first week and fifth week) during radiation treatment - Participants will be monitored throughout the treatment for side effects, with photographs of the treatment area and frequent blood tests. - Following the end of radiation, participants will have followup visits for 1 year with blood tests and imaging studies to evaluate the response to treatment.
NCT01324141 — Anal Cancer
Status: Terminated
http://inclinicaltrials.com/anal-cancer/NCT01324141/
Phase 2 Trial to Assess the Efficacy and Safety of Chemoradiation With 5-fluorouracil, Mytomicin C and Panitumumab as a Treatment for Anal Squamous Cell Carcinoma
Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC. Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical activity in a single report of a refractory anal canal SCC patient. Based on this background, we propose to conduct a phase II study to investigate the efficacy and toxicity of radiotherapy with the association: - 5-FU 1000mg/m2 on days 1-4 and 29-32 - Mitomycin C 10mg/m2 on days 1 and 29 - Panitumumab 6 mg/kg on day 1, then every 2 weeks for 8 weeks
NCT01285778 — Anal Squamous Cell Carcinoma
Status: Completed
http://inclinicaltrials.com/anal-squamous-cell-carcinoma/NCT01285778/
Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.
NCT00955240 — Anal Cancer
Status: Terminated
http://inclinicaltrials.com/anal-cancer/NCT00955240/
Microsatellite Instability in Anal Squamous Cell Carcinomas of HIV-Positive Versus HIV-Negative Patients
The molecular mechanisms involved in squamous cell carcinoma of the anus (SCCA) are poorly elucidated. HIV-positive and renal transplant patients are at high risk for developing SCCA, indicating that immune suppression plays a facilitating role. The investigators previously demonstrated that chromosomal instability (CIN) was more prevalent in SCCA of HIV-negative than HIV-positive patients. Hence, the investigators postulate that microsatellite instability (MSI), another molecular pathway, might be a feature of SCCA progression in the HIV-positive population. Study Aims: 1. to determine the prevalence of MSI in paraffin-embedded tumor specimen of 15 patients from the Swiss HIV cohort who underwent surgical excision for SCCA; and 2. eventually, to test our hypothesis by assessing the MSI status of SCCA in 15 recently operated HIV-negative patients. Study Design: The study is designed in two steps: 1. Firstly, the investigators will retrieve tumor specimen from 15 HIV-positive patients, with a biopsy-confirmed diagnosis of SCCA, in three institutions. DNA from tumor and normal tissues will be extracted, and then amplified by PCR. Presence of MSI in tumors will be determined by assessing the microsatellite markers BAT25, BAT26, and CAT25. 2. Secondly, the results of molecular analysis will be compared with a population of HIV-negative patients, with the same tumors, using the same detection technique for MSI.
NCT00952874 — HIV Infections
Status: Completed
http://inclinicaltrials.com/hiv-infections/NCT00952874/
Anal Cancer Screening Study
Background: - HIV-positive men who have sex with men (MSM) have rates of anal cancer that approach those of cervical cancer in women. However, unlike cervical cancer, there is no current recommended method of screening that could be used to detect anal precancerous lesions for the prevention of anal cancer in HIV-positive MSM. - Infections by human papillomavirus (HPV) are the likely cause of cervical and anal precancer and cancer. Detecting the presence of HPV or related biomarkers has helped to identify women who may be at increased risk of cervical cancer; researchers believe that early detection of HPV or related biomarkers in MSM may be useful for anal cancer screening. Objectives: - To evaluate the effectiveness of various tests to detect cancer-causing HPV in HIV-positive men who have sex with men. Eligibility: - HIV-positive MSM that are interested in receiving anal screening for precancer Design: - HIV-positive MSM will respond to a self-administered risk factor questionnaire, and will undergo a physical exam and a high-resolution anoscopy at the participating clinic. - The clinician will then collect to anal Pap specimens from each subject for research on HPV and related biomarkers. - Participants will be followed annually for 2 years to collect additional health data for research follow-up.
NCT00914537 — Anal Cancer
Status: Completed
http://inclinicaltrials.com/anal-cancer/NCT00914537/