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Colonic Neoplasms clinical trials

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NCT ID: NCT06436976 Recruiting - Pancreatic Cancer Clinical Trials

The Effect of Probiotics ATG-F4 in Cancer Patients

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

Patients with advanced colorectal cancer or pancreatic cancer who are receiving oxaliplatin-based chemotherapy will be included. The research participants in this study will consume probiotics along with safety and anti-cancer agent side effect-related questionnaires, blood, and fecal sample collection for up to 12 weeks from the date of registration. The total duration of participation for research subjects is 12 weeks.

NCT ID: NCT06434896 Recruiting - Recurrence Clinical Trials

Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial

CrEATE
Start date: March 5, 2020
Phase: N/A
Study type: Interventional

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design). Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.

NCT ID: NCT06414304 Recruiting - Cancer Clinical Trials

Dynamics of MSI and Genomic Profile of Colorectal Cancer In the Course of Immune Checkpoint Inhibitor Therapy

BLOOMSI
Start date: June 1, 2022
Phase:
Study type: Observational

Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide. Microsatellite instability or mismatch repair deficiency occurs in 20% of CRC, and is predominantly found in non-metastatic tumors. The success of the CheckMate 142 and KEYNOTE-177 clinical trials has shifted the treatment paradigm of the MSI/dMMR CRC, which has led to the adoption of immune checkpoint inhibitors (ICI) by international treatment standards. However, despite the encouraging effects of ICI, up to 30% of patients are resistant to treatment and exhibit rapid disease progression shortly after starting ICI. On the other hand, around 30% of patients treated with ICI demonstrate prolonged responses to the treatment with a duration of response of over 40 months. Furthermore, for ~10% of patients, treatment with ICI results in pseudo-progression - a phenomenon of a short-term increase followed by the decrease of the tumor volume. Currently, the mechanisms and biomarkers associated with the response or resistance to ICI in MSI-positive CRC are largely unknown. Select studies suggest that BRAF mutations (specifically, BRAF p.V600E) might negatively affect the patients' progression-free survival following ICI, however, these data are premature. The primary hypothesis is that the clonal heterogeneity and the evolution of MSI status of MSI-positive CRC will play a role in the development of ICI treatment resistance. The primary objective of the study is to investigate the dynamics of MSI status in serial liquid biopsy samples from patients with MSI-positive tumors receiving ICI.

NCT ID: NCT06362902 Recruiting - Colon Cancer Clinical Trials

Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients.

NCT ID: NCT06340503 Recruiting - Breast Cancer Clinical Trials

Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors

Start date: July 2024
Phase: N/A
Study type: Interventional

The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.

NCT ID: NCT06338332 Recruiting - Clinical trials for Colonic Neoplasms Malignant

Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer

OCCBRIGHT
Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

Rationale: Approximately 13% (range 10-28%) of all colorectal cancer patients (CRC) present with an acute obstruction. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. Different options can be considered in the management of obstructing right sided CRC: 1) primary resection, simultaneous treatment of obstruction and tumour resection, or 2) staged treatment of the obstruction with secondary resection of the tumour. Currently, in the Netherlands, an emergency resection has been judged to be inferior to postponing surgery. Patients who present with right sided obstructive colon cancer at one of the participating hospitals are subjected to a bridge to surgery (BTS) protocol. Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer. Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel. Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient. Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events.

NCT ID: NCT06329102 Recruiting - Lymphadenectomy Clinical Trials

Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen

RCC
Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Aim of the project is to surveil results after extended lymphadenectomy for right sided colon resection for cancer with different operative techniques. Patients operated for right sided colon cancer will be involved. There are different operative methods used in terms of extend of lymphadenectomy and access (open, laparoscopic and robotic assisted) that are already implemented. The Norwegian standard operation contains less extended lymph node dissection. Patients operated by the standard method will serve as control group. Choice of access and extend of lymph node dissection in Norway is dependant on the surgeon and hospital. At Haukeland University Hospital extend and access of surgery are determined by a multidisciplinary team meeting. More radical surgery might result in more complications and the benefit for the patients in terms of oncological result and survival is uncertain. At Haukeland University Hospital, extended lymphadenectomy has been mostly performed by open surgery. During the study phase we will introduce extended lymphadenectomy by laparoscopy and robotassisted surgery. Hypothesis is that more radical surgery performed by minimal invasive surgery will result in equal or better oncological results, and less complications, shorter hospital stay and better quality of life. As method we choose a prospective observational study. All eligible patients with adenocarcinoma of the right colon without another ongoing oncological treatment for other cancers will be included. Patientdata will be prospectively registered in a web-based database. Aim of the study will be to define the optimal extend of lymphadenectomy to achieve the best oncological result. In addition, we will analyse the results dependent on the surgical access (open, laparoscopic or robotic). The assumed difference between the operative methods is small. Therefore, the study is designed and approved as a multicenter registration in order to achieve the necessary statistical power.

NCT ID: NCT06322147 Recruiting - Colon Cancer Clinical Trials

Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF WT Unresectable Liver Metastasis Right-sided Colon Cancer

Start date: June 1, 2023
Phase:
Study type: Observational

This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety.

NCT ID: NCT06293625 Recruiting - Colon Cancer Clinical Trials

Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced But Resecable Colon Cancer in the Elderly of 70 Years Old or More

FOxTROT2France
Start date: June 7, 2024
Phase: Phase 3
Study type: Interventional

Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp). Almost all of these patients undergo surgery, but many do not receive AC due to frailty (following surgery). This particularly affects patients over 70, who represent the majority of patients diagnosed with CC. FOxTROT 2, a trial to test the role of NAC in older patients.

NCT ID: NCT06281145 Recruiting - Breast Cancer Clinical Trials

Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

SRI-BrCa_CRC
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC).