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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: 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: 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.

NCT ID: NCT03875313 Terminated - Colorectal Cancer Clinical Trials

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

Start date: May 20, 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 poly adenosine diphosphate ribose polymerase (PARP) inhibitor talazoparib in participants with advanced/metastatic solid tumors.

NCT ID: NCT03856255 Terminated - Colorectal Cancer Clinical Trials

Polyp Measurement Device

Start date: June 24, 2019
Phase: N/A
Study type: Interventional

Colorectal cancer is the second-leading cause of cancer death in the United States. Colorectal cancer screening is recommended to begin at age 50 years for most men and women at average risk for this disease. Colonoscopy is a gold standard method of screening for colorectal cancer, allowing for the detection and removal of colorectal polyps, some of which can progress into malignancy. The literature has shown that the removal of polyps during a colonoscopy results in decreased incidence and mortality related to colorectal cancer. Indeed, the last decade has shown a decline in colorectal cancer incidence and mortality in adults over age 50, largely due to increased colonoscopy screening. Currently, the risk of a patient developing colorectal cancer and thus time intervals for colonoscopy surveillance post-polypectomy is determined by the number, pathology, and size of the polyps that are observed and removed during the colonoscopy procedure. Current surveillance guidelines indicate the need for a shorter interval before the next colonoscopy for patients who have one or more polyps that are 10mm or larger. In addition, different polypectomy techniques are indicated for the treatment of polyps less than 20mm in size. For example, cold forceps may be appropriate for removal of 1mm to 2mm polyps, cold snare for polyps less than 10mm, and hot-snare resection for polyps 10mm to 19mm. Yet, while the number and pathology of polyps are easily obtained and verified, it is standard practice for the size of a polyp to be assessed through endoscopist optical visualization alone, without use of an objective device or standard by which to measure it. Often, the endoscopist will compare the size of the polyp to the size of the snare loop to estimate and document the size of the polyp(s). However, with the size of a polyp being a major indicator of malignant potential as well as an indicator of appropriate polypectomy technique and surveillance intervals, a device with which to take and document accurate and objective measurements of polyps during colonoscopy holds the potential for health benefits. In addition to having a potential clinical benefit for each patient in terms of polypectomy and surveillance intervals, as an objective indicator of polyp size, this technique also holds promise for use in future studies that evaluate polyp size as an indicator of potential malignancy (or future malignancy) and for use by national clinical guidelines committees who may utilize these objective data to update future screening and surveillance recommendations.

NCT ID: NCT03724253 Terminated - Breast Cancer Clinical Trials

[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)

NeoFIND
Start date: July 3, 2018
Phase: Phase 2
Study type: Interventional

This was a Phase II, multi-center, open label, single dose study in patients with tumor types known to overexpress Gastrin-Releasing Peptide Receptor (GRPR), including breast, prostate, colorectal, Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC).

NCT ID: NCT03705013 Terminated - Colorectal Cancer Clinical Trials

Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)

Start date: October 30, 2018
Phase:
Study type: Observational

The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.