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Adenoma clinical trials

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NCT ID: NCT04805567 Not yet recruiting - Colon Polyp Clinical Trials

Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy

Start date: April 1, 2021
Phase:
Study type: Observational

Colonoscopy is a valuable tool in reducing the incidence and mortality from colorectal cancer (CRC). Older back-to-back studies evaluating novel endoscopes indicated that conventional colonoscopy misses almost 20% of adenomas. In order to improve the diagnostic accuracy of colonoscopy and to improve the adenoma detection rate (ADR) (a significant marker of quality), efforts have been made to improve endoscopic techniques, the bowel preparation, to keep slower withdrawal time, and to use new technologies and devices. Since 2012, a new accessory device (Endocuff; ARC Medical Design, Leeds, UK), which is mounted on the tip of the colonoscope has been introduced to the market. The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. Use of this device may achieve better visualization of the bowel lumen, especially behind folds, and improve stability of the instrument on withdrawal. The aim of this study is to conduct a back-to-back endoscopy study and to evaluate the contribution of Endocuff-assisted colonoscopy to the detection of missed adenomas in a mixed population of colorectal cancer (CRC) screening/surveillance and symptomatic patients.

NCT ID: NCT04710251 Not yet recruiting - Colonic Polyp Clinical Trials

Effectiveness of Using the Speedometer During Colonoscopy

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

PURPOSE OF PROTOCOL Objective: To evaluate if the speedometer based on the real-time image analysis can help endoscopists increase their withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, during colonoscopy. Hypothesis: The trial hypothesis is that use of the speedometer during colonoscopy will increase the average withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, by 1.6 minutes, possibly increasing the performance of the participating endoscopists. Our objective is to clarify the clinical benefits of this digital tool in colonoscopy. Endpoint: Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).

NCT ID: NCT04693546 Not yet recruiting - Colorectal Cancer Clinical Trials

Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening

PREVENT
Start date: June 2021
Phase:
Study type: Observational

The purpose of this study is to determine the sensitivity and specificity for LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer (CRC) and for adenoma, including advanced adenoma.

NCT ID: NCT04569591 Not yet recruiting - Pituitary Adenoma Clinical Trials

Corticotrophin-releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing s Disease

Start date: June 26, 2024
Phase: N/A
Study type: Interventional

Background: Cushing s disease is caused by a pituitary gland tumor. Patients with Cushing s disease suffer obesity, diabetes, osteoporosis, weakness, and hypertension. The cure is surgery to remove the pituitary tumor. Currently, MRI is the best way to find these tumors. But not all tumors can be seen with an MRI. Researchers hope giving the hormone CRH before a PET scan can help make these tumors more visible. Objective: To test whether giving CRH before a PET scan will help find pituitary gland tumors that might be causing Cushing s disease. Eligibility: People ages 8 and older with Cushing s disease that is caused by a pituitary gland tumor that cannot be reliably seen on MRI Design: Participants will be screened with their medical history, a physical exam, an MRI, and blood tests. Participants will have at least one hospital visit. During their time in the hospital, they will have a physical exam and a neurological exam. They will have a PET scan of the brain. A thin plastic tube will be inserted into an arm vein. A small amount of radioactive sugar and CRH will be injected through the tube. Participants will lie in a darkened room for about an hour and be asked to urinate. Then they will lie inside the scanner for about 40 minutes. After the scan, they will be asked to urinate every 2-3 hours for the rest of the day. Blood will be drawn through a needle in the arm. Participants will have surgery to remove their tumor within 3 months after the scan. Participants will then continue regular follow-up in the clinic.

NCT ID: NCT04531930 Not yet recruiting - Clinical trials for Familial Adenomatous Polyposis

Colorectal Adenoma Canceration in FAP

Start date: October 1, 2020
Phase:
Study type: Observational [Patient Registry]

The current internationally accepted treatment method for familial adenomatous polyposis is prophylactic total colorectal resection combined with endoscopic follow-up. However, total colorectal resection will bring a sharp decline in the quality of life of patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery.

NCT ID: NCT04515082 Not yet recruiting - Colorectal Cancer Clinical Trials

Colorectal Cancer Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China

Start date: August 2020
Phase:
Study type: Observational

The primary objective is to determine sensitivity, specificity, positive predictive value and negative predictive value of a bi-target stool DNA testing (the methylation status of SDC2 and SFRP2) for colorectal cancer and advanced precancerous neoplasm(including advanced adenoma and advanced serrated lesions) screening, using colonoscopy as the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. The secondary objective is to compare the performance of the bi-target stool DNA testing to a commercially available fecal immunochemical test (FIT) assay, both with respect to cancer and advanced precancerous neoplasm. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

NCT ID: NCT04464837 Not yet recruiting - Colorectal Adenoma Clinical Trials

Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm

COLDSNAP-1
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 20 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen. In this feasibility trial, the investigators try to find out if CSP with a new designed polypectomy snare is efficient and safe in terms of complete resection (R0), pathological evaluation and adverse events.

NCT ID: NCT04390802 Not yet recruiting - Pituitary Adenoma Clinical Trials

A Pilot Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Pituitary Adenomas

Start date: July 2021
Phase:
Study type: Observational

5-Aminolevulinic Acid (5-ALA) was approved by the FDA as an intraoperative optical imaging agent in patients with suspected high-grade gliomas (HGGs) in 2017. The investigators plan to administer 5-ALA to patients with pituitary tumors to demonstrate whether it can be used as an intraoperative optical imaging agent for this pathology. Overall, this pilot study will afford the overall opportunity to improve surgical management and advancement of the science of neurological and neuroendocrine disease.

NCT ID: NCT04335357 Not yet recruiting - Clinical trials for Non-Functional Pituitary Adenoma

TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas

Start date: May 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks.

NCT ID: NCT04244708 Not yet recruiting - Pituitary Adenomas Clinical Trials

The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas

Start date: February 10, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study was to determine whether radiotherapy combined with Temozolomide is more effective than radiotherapy alone in the treatment of patients with refractory pituitary adenomas. The Basic treatment was Radiotherapy over a period of six weeks, for a total dose of 54 Gy. The150 participants were randomized to use either radiotherapy plus Temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), or radiotherapy plus placebo for 6 weeks. After a 4-week break, followed by six cycles of placebo or adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle). The primary end point was Objective Response rate, the second end point was PFS. Greater response was anticipated in patients treated with Temozolomide+ radiotherapy than radiotherapy alone.