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NCT ID: NCT05830097 Recruiting - Cancer, Breast Clinical Trials

A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors

Start date: March 14, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.

NCT ID: NCT05579340 Recruiting - Cancer Colorectal Clinical Trials

Postoperative Exercise Training and Colorectal Cancer Liver Metastasis

mCRC-POET
Start date: April 2023
Phase: N/A
Study type: Interventional

Up to 25% of colorectal cancer (CRC) patients are diagnosed with liver metastases, which is the most common site of metastasis, already during the primary tumor diagnosis. Another 30% of the patients will develop liver metastases at a later stage. Even though patient can be treated by surgical resection of the metastatic tumor, 50-75% of the patients experience a relapse in less than two years. Due to the high probability of relapse, mCRC patients undergo multiple rounds of surgery and adjuvant treatment (chemotherapy/radiotherapy) which results in substantial physical de-conditioning. Physical activity has been shown to increase the progression-free survival rates in mCRC patients, when applied post-diagnosis. Increased cardiorespiratory fitness (VO2peak) at the time of diagnosis among CRC individuals has been associated with lower risk of all-cause mortality. Although data on the effect of chronic exercise on VO2peak have emerged, thus far, there is no randomized clinical trial that has investigated the effects of exercise training in mCRC patients early after surgical treatment with curative intent. Therefore, this project aims to address the beneficial effect of structured exercise training primarily on VO2peak and tumor recurrence in mCRC patients immediately after surgical treatment and while they are undergoing adjuvant chemotherapy/radiotherapy. A total of 66 participants will be recruited from the Department of Surgery and Transplantation, Rigshospitalet and randomly allocated to a standard care control group (n=22), standard care plus 150 min/week exercise training (n=22) or standard care plus 300 min/week exercise training (n=22). Participants will undergo exercise training for 6 months, starting immediately after surgery, and they will be followed for additional 6 months. Tumor recurrence will be evaluated up to 3 years after training initiation.

NCT ID: NCT05573022 Recruiting - Cancer, Breast Clinical Trials

Impact of a Patient Decision Aid Intervention

IMPACTT
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Studies evaluating decisions aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. However, timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient's engagement in and preparation for the decision making process in a randomised, controlled trial comparing an electronic pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived levels as well as an observed level of shared decision making.

NCT ID: NCT05536089 Recruiting - Cancer Colorectal Clinical Trials

ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

Start date: September 5, 2022
Phase:
Study type: Observational [Patient Registry]

In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical resection.

NCT ID: NCT05227261 Recruiting - Cancer, Breast Clinical Trials

Early Detection of Five Common Cancers Using the ctDNA Analysing Test

K-DETEK
Start date: April 10, 2022
Phase:
Study type: Observational

This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA). Primary objective: To evaluate the performance characteristics of the blood ctDNA test in early detecting cancers. Secondary objectives: - To evaluate the performance characteristics of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests. - To determine the risk of cancers development in the high-risk population, as compared to that in the moderate-risk group.

NCT ID: NCT04874883 Recruiting - Diarrhea Clinical Trials

Effect of the Use of Symbiotics in Patients With Colon Cancer

Start date: December 1, 2019
Phase: Phase 4
Study type: Interventional

Due to the high incidence, cancer and the concomitant presence of malnutrition are currently a worldwide public health problem. The loss of weight and body tissues is a common condition in cancer patients with lesions of the airways and digestive tract and is related to anorexia and the presence and duration of gastrointestinal symptoms, such as diarrhea. The latter directly interferes with the progression of enteral diets, which are administered in order to provide adequate nutritional support for the recovery of patients and nutritional status. In this sense, the importance of measures to help reduce diarrhea episodes is reinforced, aiming at the adequate infusion of enteral diets and, consequently, nutritional needs. It is known that the use of antimicrobials is closely related to the increased incidence of nasocomial diarrhea, as it facilitates colonization by pathogenic bacteria, such as Clostridium difficile. In addition, nosocomial diarrhea is a very relevant occurrence due to the financial burden it causes for the hospital institution, which can also worsen the patient's clinical condition, since he is weakened due to the underlying disease. Despite these important aspects, studies carried out with the aim of reducing diarrhea episodes in patients with airway and digestive lesions are still not described in the literature. In this context, the use of symbiotics presents itself as a possibly beneficial alternative, considering the role of probiotics and prebiotics in the modulation of intestinal function. In this sense, this work aims to evaluate the impact of perioperative supplementation with symbiotic on clinical outcomes and intestinal function of patients with colon cancer and digestive airways undergoing colorectal resection. It is assumed that the use of symbiotics could have better results than the use of probiotics and isolated prebiotics.

NCT ID: NCT04592003 Recruiting - Cancer Colorectal Clinical Trials

French Colorectal ESD Cohort in Experts Centers

FECCo
Start date: January 1, 2020
Phase:
Study type: Observational

Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR. Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures. A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.

NCT ID: NCT04258813 Recruiting - Hypertension Clinical Trials

Onco-primary Care Networking to Support TEAM-based Care

ONE TEAM
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with >1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be ~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

NCT ID: NCT04232748 Recruiting - Weight Loss Clinical Trials

Change in Body Weight During Treatment of Advanced Colorectal Cancer

Start date: January 1, 2019
Phase:
Study type: Observational

Colorectal cancer (CRC) is a significant and growing health burden in Hong Kong. According to data from Hong Kong Cancer Registry, CRC ranked the first in incidence and the second in mortality, with around 5,000 new cases diagnosed and more than 2,000 cancer-related mortality in 2014. The investigators aim to evaluate the association between serial weight change during first line treatment and outcomes in patients with metastatic CRC.

NCT ID: NCT04189055 Recruiting - Cancer Colorectal Clinical Trials

Cetuximab as Salvage Therapy in Patients With Neo Wild-type RAS/RAF Metastatic Colorectal Cancer With Liver Metastases.

CETIDYL
Start date: January 7, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the efficacy of cetuximab or cetuximab-irinotecan in patients with neo wild-type colorectal cancer who have been previously treated for metastatic disease. Patients will be included in cohort #1 or cohort #2. The inclusion in cohort #2 will start when the results of the cohort #1 are available. Patient will receive either cetuximab alone (cohort #1) or cetuximab with irinotecan (cohort #2).