Colo-rectal Cancer

The NSABP FC-13 study is being done to determine if using immunotherapies alone or in combination with other drugs will delay or prevent colorectal cancer from coming back in patients with colorectal cancer who are ctDNA-positive after their treatment. Immunotherapeutic drugs (immunotherapies) act on different proteins on the surface of cells of the immune system and trigger the immune system to destroy cancer cells. The drugs being studied in NSABP FC-13 are cemiplimab, fianlimab, and REGN7075.

The goal of this clinical study is to learn whether a prehabilitation program can improve recovery after major abdominal surgery in adults with cancer who are receiving treatment before surgery. Prehabilitation is supportive care given before surgery to help patients prepare physically, nutritionally, and emotionally. The main questions this study aims to answer are: 1. Does prehabilitation reduce the number of participants who die or have serious complications within 30 days after surgery? 2. Does prehabilitation improve physical strength and fitness, nutritional status, emotional well-being, and quality of life before surgery? 3. Does prehabilitation affect the length of the hospital stay after surgery, the time it takes to start additional cancer treatment after surgery, or the ability to complete recommended additional treatment? Participants will take part in a prehabilitation program during their treatment period before surgery. The program includes visits with physical therapy, nutrition, and health psychology. Participants will meet with each specialty at least twice before surgery. They will also complete questionnaires and tests that measure physical function, diet and weight, emotional well-being, and quality of life. After surgery, information about recovery and additional cancer treatment will be collected from medical records for up to 120 days. Researchers will compare the outcomes of participants who receive the prehabilitation program with outcomes from similar patients who previously received care at Fox Chase Cancer Center but did not participate in this study.

The AIDPRO-CRC trial aims to improve outcomes for patients undergoing surgery for colorectal cancer by using artificial intelligence (AI) to assist surgeons in risk assessment. The trial will evaluate whether AI can help surgeons better predict the risk of complications and death, leading to improved care, fewer complications, and better use of healthcare resources. In this nationwide, randomized clinical trial, participants will be divided into two groups. One group will have their risk assessed by a surgeon using standard clinical methods, while the other group will have their risk assessed by a surgeon using AI assistance. Based on the risk level, patients will receive varying levels of perioperative care. The AI-assisted risk assessment aims to tailor the treatment more precisely to each patient's individual needs, precisely allocating care to those who need it to more efficiently allocate heath system resources while having no deterioration in patient outcomes. The primary hypothesis is that AI-assisted risk assessment will lead to more efficient and economic patient care without a deterioration in patient outcomes. The trial also aims to explore clinician satisfaction with the platform and its perceived effect. This is paired with a substudy exploring the variability of suggested treatment plans by clinicians with and without access to the MDT presentation platform. The trial will include patients at seven hospitals across Denmark, involving patients diagnosed with colorectal cancer who are scheduled for curative surgery. All patients will receive standard treatment according to national guidelines, with the only difference being the modality of risk assessment. For the evaluation of the clinicians satisfactory with the device and the substudy of variability of suggested treatment plans, the trial will enroll clinicians using the device. This study is a researcher-initiated, nationwide, randomized clinical trial involving patients diagnosed with colorectal cancer across eight hospitals in Denmark. Participants will be randomly assigned to one of two groups: AI-assisted risk assessment or standard surgeon-led assessment. The intervention focuses on optimizing perioperative care based on individual risk levels determined by either AI or the surgeon's clinical judgment. The study builds on a successful pilot project (AID-SURG) that showed promising results in reducing complications, hospital stays, and readmissions.

Prospective, observational, minimal-risk study evaluating decision-making, decisional conflict, intention to undergo complete diagnostic evaluation (CDE), and colonoscopy completion after a positive Shield TM blood-based colorectal cancer screening test result.

Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors

This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.

A Study on the Characteristics of Colorectal Cancer by Age and sex.

This study is a single-center, prospective, randomized, single-arm phase II clinical trial designed to evaluate the safety and efficacy of FULIRI chemotherapy regimen combined with targeted therapy (bevacizumab/cetuximab) as first-line conversion therapy for colorectal cancer with liver metastases. Eligible patients with colorectal cancer and liver metastases, after signing informed consent, received FULIRI chemotherapy combined with bevacizumab/cetuximab targeted therapy. Efficacy was assessed after every four treatment cycles, followed by multidisciplinary team (MDT) discussion regarding potential surgical resection, ablation, or stereotactic radiotherapy. The primary endpoint was the objective response rate (ORR), and secondary endpoints included: disease control rate (DCR), R0 resection rate of liver metastases, progression-free survival (PFS), 3-year/5-year survival rates, and the incidence of acute toxicities of any grade and grades 3/4.

The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE) to evaluate the longitudinal performance of Shield in an average risk population at a second round of testing for individuals between the ages of 45 and 81 at average risk of CRC using colonoscopy as the reference method.

The PRO-ACTIVE study aims to develop a clinical-translational program in the field of cancer prevention in all its phases (primary, secondary, and tertiary) to intervene before the clinical and radiological manifestation of the disease. It starts with risk prediction and leads to early diagnosis of the disease or recurrence in the subclinical phase. The PRO-ACTIVE study includes the following activities: * WP1: Integrated DNA-RNA approach for the identification of hereditary markers of predisposition to tumors * WP2: Global biological and molecular analysis of the host and tumor for the prevention and monitoring of recurrences * WP3: Analysis of the immunological status for the diagnosis of primary prevention and relapses in correlation to genetic and environmental factors * WP4: Study of the tumor microenvironment for recurrence prediction

This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes.

This is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.

The goals of this study are * To evaluate the clinical utility of Talin-1 and Cripto-1 measurement in colorectal cancer patients in comparison with healthy controls. * To Compare the diagnostic significance of serum Talin-1 and Cripto-1 with traditional serum biomarker CEA

This protocol is comprised of three unblinded, randomized, single-center studies to evaluate the impact of immediate versus three-month delayed comprehensive ablative treatment on survival in newly diagnosed metastatic patients with lung (Trial 1), colorectal (Trial 2), and prostate (Trial 3) cancers

The FIND-CRC study is a prospective collection of samples and data from participants who are at average risk of developing colorectal cancer (CRC). Collected samples and data will be analyzed to evaluate the clinical performance of the Natera CRC Screening Test.

Colorectal cancer is the cancer with highest incidence in Taiwan. The disease itself and subsequent treatment cause huge impact on the physical, psychological, and spiritual parts and social role of a patient. Early diagnosis of colorectal cancer and precancerous lesions is possible. Early treatment can reduce the impact on quality of life and economics. Colonoscopy is an important tool for diagnosis of colorectal proliferative lesions. Qualified bowel preparation can enhance sensitivity and reduce false negative of the colonoscopy. However, multiple factors influence the quality of bowel preparation. This study aims to investigate whether the animation video and game-based health education is more effective and satisfying than conventional health education, and to explore the difference of knowledge dissemination and quality of bowel preparation between novel and conventional methods. This study is a randomized controlled trial and uses structural questionnaire for study participants. Before the main study, the investigators will consult professors' opinions to adjust and enhance validity of the questionnaire, and the investigators will perform pretest to calculate its reliability. The investigators will enroll participants at the out-patient-department and the health management center. Questionnaires may be completed by on-site paper or phone with internet resources. The main participants of this study are adults aged 18 and more, and planned to receive colonoscopy. The questionnaires investigate the spent time, patient satisfaction, knowledge of bowel preparation and results of colonoscopy of different approaches of health education. Multiple linear regression will be applied to calculate the possible significance difference between two kinds of health education. The investigators expect this study (1) to explore whether novel health education enhances patient satisfaction (2) to investigate the efficiency of novel health education, and (3) to compare the effect of knowledge dissemination and quality of bowel preparation between experimental and control groups. This study will develop the model of health education to facilitate holistic health care.

The investigators will use a mixed methods study i.e. focus groups involving CHC staff as well as quantitative study which involves analyzing data that is available from the EHR and DRVS population management platform.

This is an open-label, unicentre, single-arm Phase 2 study of encorafenib and cetuximab as rechallenge treatment in patients with BRAF V600E-mutant metastatic colorectal cancer after previous therapy with BRAF inhibitors-based combinations. The study aims to evaluate the antitumor activity of encorafenib plus cetuximab as a rechallenge strategy measured by progression-free survival rate at 4 months. Eligible patients (a total of 25) will receive encorafenib 300 mg (four 75 mg capsules) once daily (q.d) in 28-day cycles plus intravenous cetuximab at 500 mg/m2 every 2 weeks (Q2W). Treatment will be administered until progression, unacceptable toxicity, patient request, physician's decision or subsequent anticancer therapy.

The planned research aims to evaluate the impact of a training program on self-efficacy in patients with permanent colostomies. It highlights the importance of holistic patient education in preventing complications and improving adaptation to stomas, which can positively affect patients' quality of life and self-efficacy.

CASCADE (Colorectal Analysis for Signature Cancer Assessment Using delta-HLD Technology) is a proof-of-concept case-control study designed to evaluate the performance of delta-HLD, Epiliquid's proprietary liquid biopsy technology, for the detection of colorectal cancer. Epiliquid also integrates a proprietary bioinformatic system capable of identifying, ranking, and selecting tumor-specific methylation biomarkers for different cancer types. In this study, colorectal cancer-specific biomarkers will be evaluated in blood and tissue samples using delta-HLD technology, which enables sensitive and multiplexed detection through PCR. Study results will support the validation of Epiliquid's integrated platform as a minimally invasive and accessible diagnostic solution for colorectal cancer.

The goal of this feasibility study is to investigate whether a virtual Hospital at Home is safe and possible for patients undergoing planned minimally invasive colorectal surgery. The study aims to answer the following main questions: What are the patient- and next-of-kin-related effects, as well as the clinical and organizational effects, of home-based admission? What are the implementation barriers for a full-scale randomized controlled trial? Participants will follow a standardized protocol for their care befor, during and after surgery. However, the care after surgery will be conducted at home using telemedicine.

This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.

1. \- Evaluation of diagnostic importance of soluble programmed death ligand-1 in patient with recently diagnosed as Colorectal cancer at different stages of disease . 2. Correlation of SPDL-1 level and clinco-pathological data of patients at presentation .

This study is a prospective, open-label, dual-arm exploratory Phase II clinical trial designed to assess the efficacy and safety of cadonilimab combined with anti-angiogenic agents in patients with dMMR/MSI-H recurrent or metastatic colorectal cancer. Eligible patients are enrolled into two cohorts based on their prior exposure to PD-1/PD-L1 antibody therapy: Cohort A (immune-naive group - patients with no prior PD-1/PD-L1 treatment) and Cohort B (immune rechallenge group - patients who previously received and failed PD-1/PD-L1 therapy). All participants receive combination therapy with cadonilimab and an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib. Treatment continues until the occurrence of intolerable toxicity, disease progression, withdrawal of informed consent, loss to follow-up, death, other conditions deemed by the investigator to warrant discontinuation, or study termination-whichever occurs first. Cadonilimab treatment will not exceed two years. Tumor response is evaluated every six weeks using RECIST v1.1 criteria. Safety is assessed using CTCAE v5.0, and adverse events are recorded from the first dose to 30 days after the end of treatment.