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Anus Neoplasms clinical trials

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NCT ID: NCT03958240 Recruiting - Ovarian Cancer Clinical Trials

Deciphering Mechanisms Underlying Cancer Immunogenicity

DECIDE
Start date: January 17, 2020
Phase: N/A
Study type: Interventional

This trial is a translational, open-label, multicentric, prospective cohort study of 900 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors. The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial. Patients with any of the following tumor types may be enrolled in the trial: - Head and neck cancer, - Ovarian cancer, - Cervical cancer, - Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer), - Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer) Each tumor type will be considered as an independent cohort. For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected. Study participation of each patient will be 5 years.

NCT ID: NCT03870607 Recruiting - Clinical trials for Anal Cancer Squamous Cell

Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy SCC of the Anal Canal (BISQUIT)

BISQUIT
Start date: March 13, 2019
Phase: Phase 2
Study type: Interventional

Phase II randomized study of the use of pre-and probiotics during the definitive treatment of chemotherapy-radiotherapy (Ch-RT) for patients with localized anal canal squamous cell cancer (ACSCC) with the objective of increasing the effectiveness of conventional treatment based on the assumptions of that there is a need for research that increases the cure rates of the definitive treatment of Ch-RT in the ACSCC; ACSCC is a virus-associated tumor in many cases and therefore potentially immunogenic; immunotherapy is a promising strategy in ACSCC; and that pre- and probiotics can stimulate the immune system through modulation of the intestinal microbiota, and improve oncological outcomes.

NCT ID: NCT03792854 Recruiting - Quality of Life Clinical Trials

Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)

LANACARE
Start date: December 1, 2018
Phase:
Study type: Observational

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with definitive chemoradiation for anal cancer

NCT ID: NCT03386500 Recruiting - Radiation Exposure Clinical Trials

Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer

Start date: November 28, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

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

NCT ID: NCT03381352 Recruiting - Anal Cancer Clinical Trials

Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

Start date: December 2, 2015
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03357991 Recruiting - Hiv Clinical Trials

E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM

ELAVI-67
Start date: January 11, 2015
Phase: N/A
Study type: Observational [Patient Registry]

This study evaluates the positive and negative predictive value of E6/E7 mRNA expression for anal HSIL and its capacity to predict incident HSIL in HIV + MSM. We also analyse the cost-effectiveness of this new screening strategy. It is an ambispective study with 355 participants and a follow-up period of 2 to 5 years.

NCT ID: NCT03302858 Recruiting - Anal Cancer Clinical Trials

A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand

Start date: October 2017
Phase: Phase 2
Study type: Interventional

The purpose of this research is to assess the safety and effectiveness of circumferential radiofrequency ablation (RFA) to the anal canal using the BarrxTM Ablation System to destroy anal high-grade squamous intraepithelial lesions (HSIL). The BarrxTM Ablation System used in this study comprises an RFA generator (Barrx™ FLEX) and the BarrxTM Anorectal Wand. The generator and wand are cleared by the Food and Drug Administration (FDA) for human use and the wand is specifically cleared for treatment of anal intraepithelial neoplasia (AIN). AIN is a precancerous condition. HSIL is an advanced form of AIN. The presence of HSIL has traditionally warranted treatment. RFA has been shown in many studies to effectively and safely destroy precancerous cells in a condition called Barrett's esophagus, which is a precancerous condition of the esophagus (the swallowing tube). Recent studies have shown that RFA may offer the same benefits for those with HSIL in the anal canal. In particular, ablation of the entire circumference of the canal seems to reduce recurrence of HSIL in other locations of the anal canal. This study will last between 12 to 15 months. Subjects will be required to undergo 5 to 8 study visits as outlined below that are carried out by the study doctors or the physician assistant. Most visits will last approximately one hour. Some may be shorter and some may be longer. Up to seventy (70) volunteers will participate in this study at several locations.

NCT ID: NCT03241680 Recruiting - Anal Carcinoma Clinical Trials

Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)

Start date: August 2, 2017
Phase: N/A
Study type: Interventional

Cervical cancer is the third most frequent neoplasm in Brazilian women (estimated risk of 15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer. This high incidence is explained by the pre-neoplastic lesions of the cervix being probably related to the practice of unsafe sex and to a poor local immune response against HPV. Human papillomavirus (HPV) infection affects people of any age, although it is more common in young people, probably due to increased sexual activity in that period. The association between high-risk HPV and anus neoplasm in men and women with immunodeficiency or immunosuppression has been confirmed and measures related to surveillance are standardized. In patients without immunodeficiencies, this association is still unclear, which may contribute to the lack of adequate standards to diagnose HPV and prevent cancer of the anus. The frequency of the cancer of anus previously considered low, is currently in considerable elevation, mainly squamous cell carcinoma (SCC). The causal relationship between this virus and cancer of the cervix and the anus is established. These facts have motivated the inclusion of this disease as STD, which justifies the necessity of adopting surveillance measures in the clinics of sexual, gynecological and urological diseases. Cancer of the anus, when diagnosed in the early stage, makes healing possible with less aggressive treatments, but in the advanced stage, abdominoperineal amputation is necessary. Concerned about possible anal cancer, some gynecologists have referred patients with genital HPV to search for anal infection.

NCT ID: NCT03221400 Recruiting - Gastric Cancer Clinical Trials

PEN-866 in Patients With Advanced Solid Malignancies

Start date: August 29, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

NCT ID: NCT03133286 Recruiting - Cancer Clinical Trials

Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

RADIANT
Start date: April 6, 2017
Phase:
Study type: Observational

Collect blood samples and associated clinical data prior to, during, and post radiation treatment.