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Rectal Neoplasms clinical trials

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NCT ID: NCT04222530 Not yet recruiting - Early Rectal Cancer Clinical Trials

The Diagnosis of Invasive Depth of Early Rectal Cancer

Start date: January 28, 2020
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to compare the accuracy of linear endoscopic ultrasonography and magnified narrowband endoscopy in the diagnosis of invasive depth of early rectal cancer, and to provide more powerful evidence for the choice of surgical methods for early rectal cancer. Patients with early rectal cancer who will be examined by endoscopic ultrasonography or magnifying narrowband endoscopy in the department of gastroenterology and general surgery will be examined by linear endoscopic ultrasonography or magnifying narrowband endoscopy to examine the depth of invasion of early rectal cancer, and the results are compared with the postoperative pathological results of the patients as the gold standard. It provides strong evidence that the accuracy of linear endoscopic ultrasonography in judging the invasive depth of early colorectal cancer is not inferior to that of magnifying narrowband endoscopy.

NCT ID: NCT04200027 Not yet recruiting - Rectal Cancer Clinical Trials

Robotic vs. TaTME Rectal Surgery (ROTA STUDY)

ROTA
Start date: November 15, 2021
Phase:
Study type: Observational [Patient Registry]

Background Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME). Both approaches have distinct advantages and limitations however there have been no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experienced surgeons. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve and hence the true oncological outcomes and clinical benefits cannot be measured accurately. The primary objective of this pilot study is to conduct a multicentre prospective trial to investigate clinical outcomes, in particular disease free survival (DFS) in patients undergoing RLAR and TaTME. The additional goal is to investigate other efficacy measures, complications rates, recruitment feasibility and protocol refinement. Method This pilot study will be a prospective, observational, case-matched, two -cohort, multicentre designed to investigate the oncological and clinical outcomes of patients with mid-to-low, non-metastatic rectal cancer undergoing low anterior resection (LAR) using robot-assisted surgery ( RLAR), or transanal total mesorectal excision (TaTME). The inclusion criteria consist of experienced surgeons defined as 60 prior procedures with RLAR or TaTME to meet the enrolment criteria for the RLAR and TaTME arm, respectively. Successful oncological and clinical outcomes are defined as circumferential resection margin (CRM) ≥1 mm with minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Local and distal recurrence rates with DFS over 3 years will be measured as primary outcome. Secondary and exploratory endpoints will include length of hospital stay, intraoperative time, intraoperative blood loss, harvested lymph nodes, distal resection margin, incompleteness of mesorectum, CRM involvement, unplanned conversion rates, 30-days postoperative complications and overall recurrence rate. The Quality of life assessment questionnaires will be performed preoperatively, 6 months and 12 months after reversal of ileostomy. Propensity score matching will be used to minimize bias from the nonrandomized treatment assignment. The RLAR and TaTME cohorts will be matched by propensity scores accounting for factors significantly associated with either undergoing robotic surgery or TaTME occurrence on logistic regression analysis. Ethics and Dissemination The medical ethical committees of all the participating countries will be involved in approving the study protocol. Results of the primary and secondary end points will be submitted for publication in peer-reviewed journals.

NCT ID: NCT04189393 Not yet recruiting - Colorectal Cancer Clinical Trials

Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery

MA-PPING
Start date: January 1, 2020
Phase:
Study type: Observational

The MA-PPING is a multicenter prospective observational study that includes patients undergoing surgery for gastrointestinal cancer. The study aims to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer during their surgical patient journey from the moment of diagnosis until full recovery (three months after surgery).

NCT ID: NCT04154124 Not yet recruiting - Rectal Cancer Clinical Trials

Applying PET/MR in Rectal Cancer.

Start date: November 23, 2019
Phase: N/A
Study type: Interventional

The use of the novel recently introduced PET/MR scanner is believed to be promising in RC management, providing great anatomical details and detailed metabolic characterization. Preliminary data indicate it may become a strong imaging modality for staging of RC and has the potential to be used as a predictive tool guiding individualized therapy in patients receiving nT, but confirmation on prospective studies is mandatory. The use of radiomics as analysis approach may assist in achieving a better understanding of the obtained image data, and thus a more accurate disease assessment. Objectives 1. To preliminary assess the potential diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT. 2. To preliminary assess the potential value of PET/MR in predicting pMR to nT. 3. To use radiomics analysis of PET/MR data to develop a quantification clinical tools that allow a more accurate and comprehensive assessment of RC patients.

NCT ID: NCT04127734 Not yet recruiting - Rectal Cancer Clinical Trials

Treatment of Anastomotic Leakage After Rectal Cancer Resection

TENTACLE:R
Start date: April 1, 2020
Phase:
Study type: Observational

The TENTACLE: Rectum study is a multinational retrospective cohort study that includes patients with anastomotic leakage after rectal cancer resection. The study aims to develop an anastomotic leakage severity score and to evaluate the efficacy of different treatments of anastomotic leakage.

NCT ID: NCT04103372 Not yet recruiting - Rectal Cancer Clinical Trials

Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.

PRESERVE
Start date: November 2019
Phase: N/A
Study type: Interventional

This multicentre, prospective, randomised, feasibility trial aims to change UK practice by enabling more patients with early rectal cancer to safely undergo local excision rather than major surgery thus maintaining quality of life without compromising survival outcomes.

NCT ID: NCT04098471 Not yet recruiting - Rectal Cancer Clinical Trials

Simple Transanal Local Excision,Transanal Local Excision Following Radiotherapy Versus Total Mesorectum Excision for the Treatment of the Ultra-low T2N0M0 Rectal Cancer

Start date: December 2019
Phase: N/A
Study type: Interventional

A randomized controlled clinical trial to compare the short and long term outcomes of simple transanal local excision,transanal local excision following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer

NCT ID: NCT04090450 Not yet recruiting - Clinical trials for Rectal Adenocarcinoma

Optimisation of Radiotherapy in Rectal Cancer (ORREC)

ORREC
Start date: September 23, 2019
Phase:
Study type: Observational

This is a retrospective study using images acquired routinely for diagnosis of rectal cancer to see if these could be used to predict responses to radiotherapy treatment and if it can, whether the treatment can be optimised to produce better outcome for patients. Using a clinical database, patients who have had neo-adjuvant chemo-radiotherapy will be recruited, their diagnostic images and radiotherapy planning scan will be obtained. By use of imaging registration and clinical information, the question of why some patients respond well to radiotherapy and some don't could be answered.

NCT ID: NCT03975049 Not yet recruiting - Rectal Cancer Clinical Trials

Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Start date: August 2019
Phase: Phase 3
Study type: Interventional

Preoperative radiation with single agent chemotherapy as sensitizer is the standard care of locally advanced rectal cancer. Local irradiation significantly increases surgical complications and impairs quality of life. Combination chemotherapy alone seems promising and provides similar benefit to chemoradiation as neoadjuvant therapy. Early administration of systemic therapy is also proved beneficial for long-term survival. The purpose of this study is to compare the efficacy of chemotherapy alone with short-term modified FOLFOXIRI or long-term mFOLFOX with standard chemoradiation as neoadjuvant therapy for locally advanced rectal cancer.

NCT ID: NCT03910283 Not yet recruiting - Clinical trials for Lymphoma, Large B-Cell, Diffuse

Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Mindsets are lenses or frames of mind that orient individuals to a particular set of expectations and associations. This study aims to leverage specific and empirically supported mindsets (i.e., 'cancer is manageable' and 'the body is capable') to reduce distress and improve physical health and psychological wellbeing in patients with cancer being treated with curative intent. This intervention will take the form of several brief documentary style film segments which feature both cancer survivors and experts in the fields of Oncology, Psychology, and Psychiatry. Although no mindset-targeted interventions have been studied in cancer patients to date, other psychosocial interventions have demonstrated efficacy in treating emotional distress and improving quality of life in this population. However, compared with these standard interventions, mindset interventions need not be lengthy, complex, or costly to yield major effects. Thus, this project aims to lay the groundwork for future scalable and efficient interventions that can meaningfully reduce distress and improve health and wellbeing in this population.