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Colorectal Cancer clinical trials

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NCT ID: NCT05368688 Terminated - Colorectal Cancer Clinical Trials

Microbiome in Colorectal Cancer Onset and Progression

Start date: June 30, 2022
Phase:
Study type: Observational

This is an observational study with the goal to improve the robustness of the scientific evidence linking Fusobacterium nucleatum (Fn) and/or other microorganisms to colorectal cancer (CRC) onset and/or progression. This is an approximately three-year study. There are two phases to this study, including: 1) pilot phase, 2) full study. There are also five arms in this study including cancer-free, pre-cancerous, and Colorectal cancer stages (I-III). The pilot study will include the recruitment of 50 participants per group (i.e., total of 250 participants). The full study will have an additional 150 participants per group (total of 1,000 participants). This study will recruit using clinical sites in the United States. There are 5 timepoints in this study. If the participants are found to be medically eligible through diagnosis and medical information, they will provide samples (including: saliva, blood, urine, stool and tumor biopsy) at each timepoint and during the study. They will also answer health and wellness questions during this study. Additional data collection, including medical data, biopsies and other biological samples might happen at interim timepoints in case of adenoma/cancer disease progression (recurrence, metastasis). The participant's healthcare provider will determine if additional biopsies are required as a part of the standard of care. If collected, additional samples will be sent for research purposes.

NCT ID: NCT05018325 Terminated - Colorectal Cancer Clinical Trials

Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy

Start date: August 30, 2021
Phase: N/A
Study type: Interventional

The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.

NCT ID: NCT04664543 Terminated - Colorectal Cancer Clinical Trials

Efficacy of Free Versus Low Residue Diet as Preparation for Screening Colonoscopy

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

One tricky aspect of the recommendations for colonoscopy prep is diet. This has a significant impact on the experience of the patient or participant in the screening program and, on the other hand, low adherence has been found in some studies despite a potential Hawthorne effect . It is noteworthy that despite its impact on patient experience, it is an area for which little evidence is available, which is why the guidelines give low-quality recommendations and there is probably considerable variability in clinical practice . In the early days of colonoscopy, a liquid diet for 48 hours was mainly recommended, although some centers indicated a low-residue diet or even the commercially available NASA astronaut diet. Later, the indication for a liquid diet was consolidated until finally numerous studies were published in favor of a low-residue diet, managing to increase tolerance and the quality of the preparation . A limitation of the preparation studies must be borne in mind that the colon cleansing rating scales were not introduced until 1999 when the Aronchick scale was published. Although there is solid evidence in favor of a low-residue diet versus a liquid diet, the investigators do not have evidence on how many days of a low-residue diet should be recommended, and this is reflected in the ESGE (European Society of Gastrointestinal Endoscopy) and ASGE (American Society of Gastrointestinal Endoscopy) guidelines . A randomized clinical trial comparing 3 days versus 1 day of a low residue diet has recently been published . There were no statistically significant differences in the rate of adequate preparations (82.7% vs. 85.6% OR 1.2 95% IC 0.72 to 2.15). However, this study has limited statistical power and a design that allows a non-inferiority analysis has not been followed. In relation to this, our research group is finalizing a non-inferiority clinical trial in whose intermediate analysis, with 421 participants, the non-inferiority of 1 day of diet is fulfilled (rate of poor preparation in 1 day 0.95% vs. 4.74% in 3 days; d + 5%, difference -3.78% IC -6.88% to -1.12%) (38). It is likely, taking into account the available evidence and its evolution, that diet plays a secondary role in preparation. Although no studies designed to directly assess this have been conducted, the research group has indirect data. Walter et al, under the hypothesis that the impact of the fractional preparation and the new preparations on the preparation diminished the importance of the diet, conducted a non-inferiority clinical trial between 2012 and 2013 in which they randomized the patients to follow a diet liquid versus low residue for one day and fractional preparation with Moviprep (39). They established a non-inferiority margin of -13.5%. Their results show a rate of good preparation (Boston> 5) in 68/72 (94.4%) in a liquid diet compared to 60/68 (88.2%) in a low-residue diet (p = 0.04) with a difference of -5.08% demonstrating non-inferiority of the low residue diet.

NCT ID: NCT04508140 Terminated - Colorectal Cancer Clinical Trials

Study of BO-112 With Pembrolizumab for Colorectal or Gastric/GEJ Cancer With Liver Metastasis

Start date: June 17, 2020
Phase: Phase 2
Study type: Interventional

This is an open, single arm, multicenter phase 2 trial in which BO-112 will be administered intratumorally in combination with intravenous pembrolizumab in patients with liver metastasis from colorectal, gastric or gastroesophageal junction cancers. The objective is to reverse the primary resistance that a subgroup of patients from these tumors having microsatellite stability present to the PD-1 inhibitors. Treatment will be administered every 3 weeks, with the exception of the first cycle, in which BO-112 will be also administered on D8, for up to 2 years. The primary objective is overall response rate based on RECIST 1.1 and safety, specifically referred to treatment emergent adverse events (TEAEs) with severity ≥ Grade 3 related to the study treatment (NCI-CTCAE v 5.0). The secondary endpoints include other efficacy endpoints (duration of response, disease control rate, progression-free survival, overall survival at 6 months, all based on RECIST 1.1, and overall response rate based on a specific tumor assessment criteria to evaluate the response to immunotherapies, IRECIST) and safety, in this case considering the number and proportion of subjects with treatment TEAEs (any grade) . In addition, the changes in the tumor microenvironment induced by the injection of BO-112 will be also evaluated as exploratory endpoints.

NCT ID: NCT04172597 Terminated - Breast Cancer Clinical Trials

A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies

Start date: December 23, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.

NCT ID: NCT04165031 Terminated - Colorectal Cancer Clinical Trials

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

Start date: November 28, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.

NCT ID: NCT04158349 Terminated - Colorectal Cancer Clinical Trials

Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer

IPOX-FOLFIRI
Start date: March 22, 2021
Phase: Phase 1
Study type: Interventional

This study is a prospective, multi-center, open-label phase I trial designed to determine the maximun tolerated dose of IP oxaliplatin when given in combination with mFOLFIRI.

NCT ID: NCT04077372 Terminated - Colorectal Cancer Clinical Trials

Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers

Start date: September 16, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether standardized implementation of a scripted template for discussing important issues that arise near the end of life improves the care of those who have advanced cancer.

NCT ID: NCT04034355 Terminated - Colorectal Cancer Clinical Trials

Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer

POLAR-A
Start date: January 7, 2019
Phase: Phase 3
Study type: Interventional

This study is to evaluate PledOx for prevention of chronic chemotherapy induced peripheral neuropathy induced by oxaliplatin in patients with Stage III or high-risk Stage II colorectal cancer (CRC).

NCT ID: NCT03957096 Terminated - Colorectal Cancer Clinical Trials

A Safety Study of SGN-CD47M in Patients With Solid Tumors

Start date: July 17, 2019
Phase: Phase 1
Study type: Interventional

This trial will study SGN-CD47M to find out whether it is an effective treatment for different types of solid tumors and what side effects (unwanted effects) may occur. The study will have two parts. Part A of the study will find out how much SGN-CD47M should be given for treatment and how often. Part B of the study will use the dose found in Part A and look at how safe and effective the treatment is.