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Colorectal Cancer clinical trials

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NCT ID: NCT03957902 Recruiting - Colorectal Cancer Clinical Trials

Assessment of Direct Biomarkers of Aspirin Action to Develop a Precision Chemoprevention Therapy of Colorectal Cancer

Start date: May 6, 2019
Phase: Phase 2
Study type: Interventional

Acetylsalicylic acid (ASA) seems the ideal colorectal cancer (CRC) chemoprevention agent. Several ongoing trials are testing the effect of ASA as co-therapy in CRC. The mechanisms of action, the appropriate dose and the ideal target population are unknown. The investigators have demonstrated that doses of 100 mg of ASA induce direct and partial but persistent acetylation of the cyclooxygenase (COX) isoenzyme COX-1 in the normal colorectal mucosa. The primary objective is to perform a study of aspirin by using a proteomic assay for comparing platelet COX-1 and CRC mucosal COX-1 after different doses of ASA. Secondary objectives are: the measurement of prostaglandin E2 (PGE2) and phosphorylated S6 protein (p-S6) levels in CRC mucosa, the assessment of indirect biomarker of aspirin action (serum thromboxane B2 (TXB2) and urinary levels of 11-dehydro-TXB2 (TX-M)), the evaluation of systemic biomarkers of inflammatory/tumorigenic COX-2 by assessing urinary levels of major metabolite of PGE2 (PGE-M). Methods: Phase II randomized clinical trial in 60 patients with newly diagnosed CRC in 3 groups of 20 patients receiving 100 or 300 mg/day, or 100 mg/12 hours of enteric-coated ASA for 3±1 weeks, prior to definitive treatment by surgery. Main outcome: Acetylation of COX-1 and COX-2. Eicosanoid levels in target organs. Expected results: Evidence for the current uncertainty about the mechanisms of action and the dose required to obtain the best chemopreventive effect with ASA in CRC. Confirm acetylation of COX as a key biomarker of efficacy with ASA.

NCT ID: NCT03955510 Recruiting - Colorectal Cancer Clinical Trials

Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis

Start date: May 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to study the impact of Western lifestyle, including moderate alcohol consumption and delayed eating patterns on studying individuals' susceptibility to colorectal cancer. This study aims to increase our ability to identify individuals at risk for colorectal cancer in the future. Each subject will experience four conditions (each for one week in duration with a week +/- 2 days wash-out in between): (1) "right-time eating" / no alcohol, (2) "right-time eating" / with alcohol, (3) "delayed-eating" / no alcohol, (4) "delayed-eating" / with alcohol. The order of experiments will be randomized [concealed randomization]. All subjects will undergo unprepped sigmoidoscopy after each week of intervention. In Aim 2, all subjects will have an option to undergo a 24h circadian assessment in the Biological Rhythms Research Lab after each week of intervention. The Investigator will assess (i) central circadian rhythms by collecting hourly salivary samples for melatonin assays and (ii) peripheral rhythm in the intestinal tract by buccal swabs once every 2h (12 time points) as well as by rectal sampling twice (every 12 hr). For Aim 3, sigmoidoscopy without sedation will be used to obtain colonic samples as the safe method compared to colonoscopy, which has some small but finite risks associated with the procedure (e.g, bleeding or perforation) as well as sedation.

NCT ID: NCT03950154 Recruiting - Colorectal Cancer Clinical Trials

Study of Chemotherapy Combination With Autologous Cell Immunotherapy in the Recurrent and Metastatic Colorectal Cancer

Start date: June 1, 2019
Phase: Phase 3
Study type: Interventional

This study evaluates the effect and safty of PD-1 monoclonal antibody-activated autologous peripheral blood lymphocyte (PD1-T) combined with XELOX and bevacizumab in the first-line treatment of recurrent and metastatic colorectal cancer. Half of participants receive PD1-T combined with XELOX and bevacizumab, while the other half will receive XELOX and bevacizumab.

NCT ID: NCT03946917 Recruiting - Colorectal Cancer Clinical Trials

JS001 Combined With Regorafenib in Patients With Advanced Colorectal Cancer

Start date: March 12, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Colorectal cancer is one of the most common malignancies in China. Regorafenib is the standard multi-kinase inhibitor for refractory advanced colorectal cancer. In mice, regorafenib combined with anti-PD-1 was shown superior to regorafenib, which has not yet been verified in humans. JS001 is the Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma. This study is the first multi-center, open-label, phase I/II clinical trial to evaluate tolerability, safety and efficacy of JS001 in combination with regorafenib tablet in patients with MSS/MSI-L/pMMR, relapsed or metastatic colorectal cancer who have failed or can not tolerate fluorouracil, oxaliplatin and irinotecan based systemic treatment. The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of regorafenib tablet in this regimen, and select an acceptable safe dose for the phase II clinical trial to further determine safety and efficacy of this combination regimen in patients with metastatic colorectal cancer.

NCT ID: NCT03930888 Recruiting - Colorectal Cancer Clinical Trials

Nutritional Support in Patients Undergoing Surgical Treatment of Colorectal Cancer

NISS
Start date: January 1, 2019
Phase:
Study type: Observational

According to available data, 30-60% of patients are undernourished at hospital admission. The significance of the perioperative nutrition has already been studied in the 1930s. The outcomes of published studies demonstrated that patients with basic nutrient deficiencies have a higher frequency of postoperative complications and have a significantly longer recovery period. The main aim of the this prospective clinical trial is to evaluate the loss of muscle mass and strength of the patient, the self-sufficiency and the possibility of returning to normal activities, in relation to pre-operatively served nutritional supplements in patients undergoing elective surgery for colorectal cancer.

NCT ID: NCT03928652 Recruiting - Colorectal Cancer Clinical Trials

Prognostic Biomarker for CRC

PROMOTE
Start date: April 24, 2019
Phase:
Study type: Observational

The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.

NCT ID: NCT03925662 Recruiting - Colorectal Cancer Clinical Trials

Mebendazole as Adjuvant Treatment for Colon Cancer

Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

mebendazole treating colon cancer

NCT ID: NCT03906110 Recruiting - Colorectal Cancer Clinical Trials

Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES)

Start date: January 12, 2018
Phase:
Study type: Observational

The purpose of this study is to test if including personalization in education materials about colorectal cancer screening is more effective at helping encourage people to complete colorectal cancer screening.

NCT ID: NCT03879811 Recruiting - Colorectal Cancer Clinical Trials

Determining the Effects of Temozolomide Followed by Nivolumab in Patients With Colorectal Cancer

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

The purpose of this study is to find out whether temozolomide followed by nivolumab is an effective treatment for MMR-proficient colorectal cancer, while causing few or mild side effects.

NCT ID: NCT03875313 Recruiting - Colorectal Cancer Clinical Trials

Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors

Start date: March 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor CB-839 with the PARP inhibitor talazoparib in participants with advanced/metastatic solid tumors.