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Colonic Neoplasms clinical trials

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NCT ID: NCT04084249 Recruiting - Colorectal Cancer Clinical Trials

ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.

NCT ID: NCT04080414 Completed - Colorectal Cancer Clinical Trials

Home-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence

Start date: August 2, 2019
Phase: N/A
Study type: Interventional

This 12-week, exercise study will assess the feasibility of a home-based high-intensity interval training (HIIT) program among colorectal cancer survivors and explore the impact of home-based HIIT compared to a standard home-based moderate-intensity continuous aerobic exercise program on physical outcomes linked with survival from colorectal cancer and surrogate blood markers of colorectal cancer recurrence. HIIT is a type of aerobic exercise that includes short bursts (i.e. 1-4 minutes) of vigorous exercise followed by longer periods of moderate to lower intensity exercise (i.e. 1-10 minutes). Participants in this study will be randomly assigned into a personalized home based exercise program - either high-intensity interval training (HIIT) or moderate-intensity continuous aerobic exercise (MICE). This pilot study will provide us with preliminary evidence for a larger trial aimed to compare the effectiveness of these two different types of home-based exercise programs on physical outcomes linked with survival, quality of life, and surrogate blood markers of colorectal cancer recurrence.

NCT ID: NCT04079946 Not yet recruiting - Cancer Colon Clinical Trials

The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Cancer Colon is one of the major public health problems worldwide. Complete eradication of the tumor with no recurrence or residual masses is a challenge which faces all the surgeons and medical staff all over the world. A lot of techniques were used to ensure 100 % eradication of the tumor and to cure the patients from cancer. Total Mesocolic Excision with Central Vessel Ligation is one of the recent techniques used for colon cancer surgeries. Here in the research the investigators answer the question of how this technique is superior and more beneficial in complete eradication of the tumor than the conventional surgery for colon cancer

NCT ID: NCT04070898 Recruiting - Colon Cancer Clinical Trials

Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.

Start date: September 15, 2019
Phase: N/A
Study type: Interventional

INTRODUCTION: Recommendations for peroperative bladder catheterization remain a controversial issue since it is a procedure that is not without complications. Most of the current suggestions derive from open surgery data that have been extrapolated to Enhanced Recovery After Surgery (ERAS) or Fast-Track programs ranging between 24-48 hours. The objective of the present study is to find the perfect balance with a better degree of evidence than the current one between the reduction of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery. Methods: Multicenter, prospective, controlled, randomized non-inferiority study on the management of the bladder catheter in patients undergoing scheduled laparoscopic colon surgery, randomized in two study groups: experimental group (removal of the bladder catheter after surgery ) and control group (removal of the catheter at 24 hours) after the surgical intervention. The main objective of the present study is to reduce the permanence of the bladder catheter trying to find the balance of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery As secondary objectives we will consider the decrease in the incidence of urinary tract infections within the first 30 days as well as the reduction in hospital stay and morbidity related to the bladder catheter.

NCT ID: NCT04068103 Active, not recruiting - Clinical trials for Colon Adenocarcinoma

Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery

Start date: December 16, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.

NCT ID: NCT04067778 Completed - Clinical trials for Inflammatory Bowel Diseases

IBD Neoplasia Surveillance Pilot RCT

IBDDysplasia
Start date: November 6, 2020
Phase: N/A
Study type: Interventional

To determine if random biopsies can be safely eliminated from screening of average risk persons with IBD, the investigators propose to carry out a pilot randomized control trial in which targeted biopsies in combination with random biopsies will be compared to targeted biopsies alone in terms of pre-cancerous lesion capture rate, side-effects and CRC risk. The pilot study will aim to capture 20% of the overall study population in order to evaluate the feasibility of recruiting the needed number of participants in the specified time frame, while maintaining high quality of data collection.

NCT ID: NCT04066816 Completed - Colon Cancer Clinical Trials

Ellagic Acid, Urolithin and Colonic Microbial Communities Affected by Walnut Consumption

Start date: May 20, 2019
Phase: N/A
Study type: Interventional

Briefly, this is a 28-day dietary intervention study participants will be asked to eat 2 ounces (52 grams) of walnuts every day for 3 weeks, and at the end of the study period they will come in for a colonoscopy. Participants will first start a 1-week run-in period where they will be asked to avoid foods high in ellagic acid. In addition, they will be asked to complete food surveys and two sets of 3-day dietary records, and to provide colon biopsies for this study during their routine colonoscopy, as well as a blood, and two urine and stool samples. Urine samples will be used for analysis of urolithin, ellagic acid metabolites. Stool samples will be used to assess gut microbiota changes after walnut consumption. Dietary records will be used for compliance and Food Frequency Questionnaire will be used to assess dietary habits. Lastly, the biopsy samples will be used for analysis of biomarkers and anti-inflammatory in the colon, as well as adherent microbiome to the colonic tissue. Data will be analyzed based on the urolithin phenotypes.

NCT ID: NCT04057274 Active, not recruiting - Colon Cancer Clinical Trials

Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth

AEROBIC
Start date: September 23, 2019
Phase: N/A
Study type: Interventional

This study involves drawing blood samples from men before and after they perform 30-minutes of moderate-intensity aerobic exercise. The investigators will evaluate whether adding the exercise serum to colon cancer cells in a dish can reduce the growth of the cells compared to the resting serum. Note: serum is the liquid part of the blood that carries hormones and metabolites around the body.

NCT ID: NCT04048421 Recruiting - Colon Cancer Clinical Trials

Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Colon Cancer

Start date: December 20, 2019
Phase: N/A
Study type: Interventional

This study aims to evaluate the safety and efficacy of radical colectomy with hybrid transvaginal natural orifice transluminal endoscopic surgery (hvNOTES). This is a prospective, single-arm, multicenter, uncontrolled, open-label phase II study in 55 eligible subjects with resectable colon cancer. After informed consent, patients will be sent to have hvNOTES radical colectomy by surgeons with good experience in laparoscopic colorectal surgery. Patients' demographic, operative detail and postoperative outcomes including conversion to open surgery, operating time, blood loss, pain score, resumption of gastrointestinal function, postoperative complications, length of hospital stay, sexual function, quality of recovery, recurrence rate, recurrence patterns, relapse-free survival, and overall survival will be recorded prospectively. The results of the patients will be assessed to validate safety, functional outcomes or oncologic outcomes of hvNOTES colectomy.

NCT ID: NCT04046445 Active, not recruiting - Colorectal Cancer Clinical Trials

Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer

KISIMA-01
Start date: July 22, 2019
Phase: Phase 1
Study type: Interventional

This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 (Ezabenlimab) compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies. VSV-GP is a recombinant chimeric vesicular stomatitis virus (VSV, Indiana strain Rhabdoviridae) which carries the envelope glycoprotein (GP) of the visceral non neurotropic WE-HPI strain of the Lymphocytic choriomeningitis virus (LCMV, Arenaviridae) instead of the native VSV glycoprotein (G) and is developed as integral part of the prime-boost regimen together with ATP128. The Sponsor plans to enrol 96 patients with histologically or cytologically confirmed stage IV colorectal cancer coming form three different patient populations: - Cohort 1a: 6 patients with stage IV colorectal cancer (CRC) having failed standard of care (SoC) therapies - Cohorts 1b, 2a, 2c: 30 patients with stage IV microsatellite stable/mismatch repair-proficient (MSS/MMRp) CRC being in stable disease (SD) or partial response (PR) after first line of SoC (4-6 months duration at minimum) - Cohorts 2b, 4b: 30 patients with stage IV MSS/MMRp liver-limited disease Patients eligible for this study will be enrolled in one of the 8 cohorts depending on their disease: - Patients in Cohort 1a will receive ATP128 as single agent - Patients in Cohorts 1b, 2a, 2b, 2c will receive ATP128 in combination with BI 754091 - Patients in Cohorts 3, 4a, 4b will receive ATP128 and VSV-GP128 in combination with BI 754091