Clinical Research Directory

FULIRI Plus Targeted Therapy for First-line Conversion Therapy of Colorectal Cancer Liver Metastases.

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.

Shared Decision-Making for Colorectal Cancer Screening in High-Risk First-Degree Relatives Aged 40-49

The primary objective of this study was to evaluate the impact of a constructed shared decision (SDM) intervention (offering an option between colonoscopy and immunochemical collapsible occult blood testing (fecal immunochemical test; FIT)) on improving the incidence of high colonoscopy stromal in patients aged 40-49 years with a close relative suffering from colorectal cancer, compared to standard care (direct referral for colonoscopy).

Shield Post-Approval Study Protocol

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.

Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy

Individuals with high fecal hemoglobin concentrations detected by fecal immunochemical testing (FIT) but negative findings on high-quality colonoscopy represent a clinically challenging population. Although colonoscopy is considered the gold standard diagnostic procedure, previous studies suggest that these individuals may still have an elevated long-term risk of colorectal cancer. This randomized controlled trial aims to determine the optimal surveillance strategy for this high-risk group by comparing two approaches: repeat FIT testing after two years versus direct colonoscopy after two years.

A Study of Biological, Genetic, and Constitutional Factors and Non-invasive Monitoring to Assess Personal Cancer Risks

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

EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer

The purpose of this study is to determine the immunogenicity of the CIMAvaxEGF® vaccine (that is, its effectiveness in inducing an anti-tumor immune response) in patients with metastatic KRAS/NRAS/BRAF wild-type gene colorectal cancer, when given in combination with standard therapies used in the treatment of advanced colorectal cancer.

Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection

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.

Serum Talin-1 and Cripto-1 in Colorectal Cancer

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

Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors

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.

A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

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

Colorectal Cancer Screening Outreach

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

Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial

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 AIDPRO-CRC Trial

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.

Could Computerized Tomography be an Alternative to Colonoscopies for Screening for Colorectal Cancer?

The aim of this observational study is to investigate whether computed tomography can be used as an alternative to colonoscopy in colon cancer screening. The main question the study aims to answer is: Can colon cancer screening be performed as effectively with computed tomography as with colonoscopy? Participants in the colon cancer screening group will be divided into two groups: those who underwent colonoscopy and those who underwent computed tomography. The screening effectiveness of the two methods will be compared.

Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)

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.

Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery

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.

Compare the Patient Satisfaction and Effectiveness After Novel Application-based or Conventional Health Education of Bowel Preparation for Colonoscopy

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.

Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study

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.

A Study to Characterize Encorafenib Plus Cetuximab as Rechallenge Treatment for BRAF V600E-mutant Metastatic Colorectal Cancer Patients After Previous Therapy With BRAF Inhibitors-based Combinations

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 Effect of the Training Program Given to Permanent Colostomy Patients on Self-efficacy

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.

Colorectal Analysis for Signature Cancer Assessment Using Delta-HLD

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.

Post Operative Hospital at Home After Colorectal Surgery

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.

Akkermansia Probiotics Plus Anti-PD-1 Monoclonal Antibody in MSS/pMMR Advanced Colorectal Cancer

The investigators propose to conduct a single-center, single-arm, Phase I clinical study to explore the safety and feasibility of Akkermansia probiotics combined with anti-PD-1 monoclonal antibody in patients with MSS/pMMR advanced colorectal cancer, as well as its impact on gut microbiota and the immune microenvironment.

Role of Programmed Death Ligand 1 in Colorectal Cancer

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 .