Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope

Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope

Standard colonoscopy without any additional device

Arc Endocuff (AEC 110, 120, 130, 140)

Olympus Disposable distal attachment 15mm diameter, 4mm depth

Standard colonoscope

Tobias Meister, Prof. Dr.med.

Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study

Proportion of patients having at least one adenoma

Helios Albert-Schweitzer-Klinik Northeim

Prof. Dr. med. Tobias Meister

Carcinoma

Herbal and Botanical

All Drugs and Chemicals

Cola

Group II standard colonoscope, no further device used

Endocuff Vision cap on Standard colonoscope

Endocuff group

Thomas Rösch

The aim of this study is to evaluate the effect of ENDOCUFF VISION® (caps with soft, about 1 cm long lateral feet of rubber ("Endocuff") to flatten the colon folds) on ADR in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only).

It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT).

Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®.

Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap

Colonoscopy is currently the best method for the detection of colon carcinomas and, as precursor, adenomas, since these can also be biopsied and removed. Therefore, the screening colonoscopy was introduced at the end of 2002 (covered by state insurance) from the age of 55. The main quality parameter for outcome quality is the adenoma detection rate (ADR), which correlates with the rate of the carcinomas prevented. However, since even smaller polyps, especially if they are flat or sunken, may be relevant for colon cancer development, the aim of colonoscopy should be to be able to recognize and remove as many adenomas as possible. There is a need to optimize the efficiency of screening colonoscopy by increasing the rate of adenoma detection, as it is known from many studies that approximately 15-30% of adenomas can be missed- even though the adenoma rate in the German screening colonoscopy register continues to increase over the years and currently stands at 28%.

Previous studies on the increase of the adenoma detection rate by endoscopy concerning newer endoscope technologies including conventional caps have been almost entirely negative.

For about 2 years, a newer version of ENDOCUFF VISION® caps (caps with soft, about 1 cm long lateral feet of rubber (Endocuff) to flatten the colon folds) is available which has already been used in about 8,000 colonoscopies in Germany and another 10,000 colonoscopies in Europe; there are no studies on this version of Endocuff caps.

The aim of this study is to evaluate the effect of ENDOCUFF VISION® in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only).

It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT).

A new technique for ADR improvement within colonoscopy can only be tested in a comparative study in two groups comparing the adenoma rate between the two groups. An independent gold standard does not exist in this sense, but the confirmation by the endoscopically taken histology serves as gold standard for the diagnosis adenoma. The alternative of double examinations (tandem colonoscopy) in each patient is in the setting of private practice not feasible.

Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®.

Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap

A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)

A Prospective Randomized Comparison of the Adenoma Detection Rate in Screening Colonoscopy With and Without a Disposable Cap (ENDOCUFF VISION®)

Differences in ADR with or without the new disposable ENDOCUFF VISION® cap. Hypothesis: Endocuff Vision improves the adenoma detection rate (ADR) by about 25% compared to the comparison group.

differences in adenoma subgroups (between intestinal folds with good accessibility, between intestinal folds with poor accessibility, on top of intestinal fold, behind intestinal fold )

measured by comparison with size of snare or forceps

loiw grade intraepithelial neoplasia (LGIN), high grade intraepithelial neoplasia (HGIN), sessile serrated Adenoma (SSA), Carcinoma

adjustability of adenoma by colonoscope on a score scale from 1(very good) - 6 (poor)

resection of adenoma by biopsy, polypectomy, resection by forceps, none

Norgine

Universitätsklinikum Hamburg-Eppendorf

Prof. Dr. med.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.

SBRT Prostate

William R Lee, MD

The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.

This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.

Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day

Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment

Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment

Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment

Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring \> 90 days from the end of radiation treatment

The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.

Duke University

Only Genitourinary and Gastrointestinal adverse events were reported.

Five fractions of 7.4 Gy each

SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.

Stereotactic Radiotherapy

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Joan Cahill, BSN RN OCN CCRP

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Number of Participants With Genitourinary Acute Toxicity

Number of Participants With Genitourinary Late Toxicity

Number of Participants With Gastrointestinal Acute Toxicity

Number of Participants With Gastrointestinal Late Toxicity

Disease Free Survival

Urinary Domain

Sexual Domain

Bowel Domain

Hormonal Domain

Only participants who provided responses for each domain were analyzed.

Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Antirheumatic Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Cisplatin

Cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles

cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles

José Bines, Doctorate

Otto Metzger, Oncologist

This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles. After surgery, adjuvant chemotherapy consisting of docetaxel (75 mg/m2) every 21 days was further provided for 4 cycles. Primary outcome was pathological complete response in the breast and axilla (pCR; ypT0ypN0). Secondary outcomes were safety, disease-free survival and overall survival.

This is a non-randomized, open-label, single arm, single center, phase II clinical trial. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2, intravenous \[IV\], day 1) in combination with doxorubicin (50 mg/m2, IV, day 1) and cyclophosphamide (500 mg/m2, IV, day 1) every 21 days and for a total of 6 cycles (CAP regimen). Subsequent mastectomy plus axillary lymph node dissection was performed. Pathological specimen was analyzed to assess tumor response in the breast and axilla. Adjuvant chemotherapy consisting of docetaxel (75 mg/m2, IV) every 21 days was further provided for 4 cycles. In case of tumor progression during neoadjuvant treatment, CAP was discontinued and additional local or systemic treatment was provided at the discretion of the investigator. The protocol was approved by the institutional review board of National Cancer Institute - Brazil. All patients provided written informed consent. The Brazilian Group of Breast Cancer Studies (GBECAM) and National Cancer Institute -Brazil were the academic sponsors and National Cancer Institute- Brazil was the funding source of the trial.

Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen

Phase II Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer Patients With the CAP Regimen

All data from this study was monitored by the GBECAM (Brazilian Group of studies on breast cancer) and the protocol approved by the research ethics committee of the National Cancer Institute.

The collected data are archived in the research center, available for consultation in individual clinical records by patients, in addition to the source documents and folders with all regulatory material of the study.

We are in the process of finalizing a scientific paper, to be published in an international magazine, in order to disseminate the results of the study.

Pathological complete response (pCR) assessed by the local pathology lab, and defined as the absence of tumor (invasive and/or in situ) both in the breast and axilla (ypT0 ypN0)

Safety was assessed according to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0.

DFS was defined as time from surgery to disease recurrence or death from any cause

OS was defined as time from surgery to death from any cause.

Dana-Farber Cancer Institute

Instituto Nacional de Cancer, Brazil

Oncologist

Pain

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Lidocaine

Anesthetics

Bupivacaine

spinal anesthesia : 0.5%hyperbaric bupivacaine 10-15 mg/dose injected at L3-L5

1%Xylocaine with adrenaline (Max 7 mg/kg/dose) divided to inject into each side of the spermatic cord 6-8 ml and infiltration into the scrotal incision area 3-4 ml.

Bilateral simple orchiectomy is the surgical removal of both testicles through an incision in the scrotum.

bilateral orchiectomy

Thararat Wanthawong, MD

Wattanachai Ungjaroenwathana, MD

Sahachart Atichosakun, MD

Rawisara Hongkrisadakorn, MD

The goal of this randomized controlled trial is to compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups in metastatic prostate cancer patient. The main question it aims to answer are:

• Is there a difference in the level of pain during bilateral orchiectomy between spinal anesthesia and spermatic cord block?

Participants will undergo bilateral orchidectomy. They will be randomly assigned to two groups: the group receiving spinal anesthesia and the group receiving spermatic cord block If there is a comparison group: Researchers will compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications in both groups of patients.

Objective : To compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups.

Material and Method : This Randomized Controlled Trial that collected data from prostate cancer patients who underwent orchiectomy in our institution. Patients were randomly divided into two groups; SA and SCB. Data was collected on intraoperative pain score, 1 hour post-surgery, Morphine consumption during 6 and 12 hour after surgery and complications. All data was statistically analyzed using Independent t-test and Fisher's exact test.

Inclusion criteria : Patients of all ages diagnosed with prostate cancer undergoing treatment with bilateral orchiectomy.

Exclusion criteria :

1. Patients with a history of Xylocaine allergy.
2. Patients with uncorrected bleeding disorders.
3. Patients with paralysis or neurosensory deficits
4. Patients with dementia or cerebrovascular accidents (strokes) that impair communication.
5. Patients with contraindications for spinal anesthesia, including:

   * Patient refusal of spinal anesthesia.
   * Infection at the site of spinal injection.
   * Allergy to specific types of local anesthetics, such as Hyperbaric bupivacaine.
   * Inability of the patient to cooperate with the spinal anesthetic procedure.
   * Suspicion of high intracranial pressure based on abnormal physical examination.
   * Aortic stenosis with fixed cardiac output.
   * Low platelet count.

Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy

The Feasibility of Local Anesthesia for Bilateral Orchiectomy : a Randomized Controlled Trial

Pain assessment is done using the verbal numerical rating scale, where patients rate their pain level from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable, without using any materials or equipment.

Postoperative complications assessment such as acute urinary retention and neurological complications like radiculopathy, neurological deficits, cauda equina syndrome, and paraplegia.

Sanpasitthiprasong Hospital

Principal Investigator of Urology department, Sunpasitthiprasong hospital, Ubonratchathani, Thailand

forward-viewing endoscope with a Cap attached at the tip

Denise P Guimarães, MD, PhD

Leonardo C Silva, MD

The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.

The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy	NCT02331836	Colorectal Poly... Colorectal Aden...	Arc Endocuff (A... Cap Standard colono...	18 Years -	Helios Albert-Schweitzer-Klinik Northeim
A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)	NCT03442738	Adenoma Detecti...	Endocuff group	55 Years -	Universitätsklinikum Hamburg-Eppendorf
Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer	NCT00941915	Prostate Cancer	SBRT Prostate	40 Years - 82 Years	Duke University
A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)	NCT03442738	Adenoma Detecti...	Endocuff group	55 Years -	Universitätsklinikum Hamburg-Eppendorf
Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen	NCT03304756	Triple Negative...	CAP	18 Years -	Instituto Nacional de Cancer, Brazil
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy	NCT02331836	Colorectal Poly... Colorectal Aden...	Arc Endocuff (A... Cap Standard colono...	18 Years -	Helios Albert-Schweitzer-Klinik Northeim
Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy	NCT06313775	Orchiectomy Spermatic Cord ... Spinal Anesthes... Pain Score Prostate Cancer	bilateral orchi...	-	Sanpasitthiprasong Hospital
The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater	NCT02867826	Ampulla of Vate...	Cap	18 Years - 99 Years	Barretos Cancer Hospital
A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)	NCT03442738	Adenoma Detecti...	Endocuff group	55 Years -	Universitätsklinikum Hamburg-Eppendorf

Spots Global Cancer Trial Database for cap

Every month we try and update this database with for cap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cap

Every month we try and update this database with for cap cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.