Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Polyps

Rectal Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Pathological Conditions, Anatomical

Herbal and Botanical

All Drugs and Chemicals

Cola

After consent, the endoscopist will perform a standard of care colonoscopy. If a polyp is found, then OCT will be used to image that polyp. Patients with polyps, regardless of number found, will have either one tubular adenoma (NICE type 2) imaged OR one hyperplastic polyp (NICE type 1) imaged. If no polyps are found, then one area of normal mucosa will be imaged. If on the rare chance a malignant appearing colonic tumor (NICE type 3) is found, this and no other polyps will be imaged with OCT.

The OCT probe is attached to an approximately 3-meter wire that is attached to the OCT fiber probe system setup. This setup consists of a power supply unit, and a control platform that controls fiber probe rotation and retraction. The OCT probe will be advanced through the colonoscope instrument channel

Optical coherence tomography probe

Vladimir Kushnir, M.D.

Colorectal cancer arises from the mucosal layer of the colon. Current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. This method is somewhat limited in that there are no readily available surface pattern or morphological classification systems with adequate sensitivity or specificity to evaluate extent of submucosal invasion (deep, superficial, or none). Optical coherence tomography (OCT) using pattern recognition is a high-resolution imaging modality. There is currently an unmet need to predict depth of invasion for colonic tumors to decide on applicability of endoscopic (endoscopic submucosal dissection or endoscopic mucosal resection) vs. surgical therapy. The investigators' hypothesis is that OCT will have a higher diagnostic accuracy for determining depth of submucosal invasion compared to existing modalities. The investigators will first aim to assess the procedural feasibility and safety of using an OCT probe during routine colonoscopy with an early feasibility study. This study will identify appropriate modifications to the device and help with development of subsequent clinical study protocols. The eventual goal is to assess the diagnostic accuracy of OCT imaging for predicting depth of invasion of colonic tumors.

Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps

Early Feasibility Study of Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps

If the proportion of the patients whose procedure length using an OCT probe during routine colonoscopy is within 5 minutes is greater than 75%, then the feasibility is defined in this study.

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

Whether OCT image is successfully captured using machine learning algorithm, coded as "good" or "noisy".

Overall agreement (OCT probe yielding results consistent with clinical pathology biopsy results) as measured by Cohen's Kappa. Overall Cohen's Kappa is a statistical measure for assessing the reliability of agreement between the two results by taking into account the element of chance. Cohen's kappa can range from 0 to 1 with 1 indicating perfect agreement and 0 indicating an agreement equivalent to chance.

Clinical pathology is the gold standard for diagnosis. Diagnosis from both OCT and clinical pathology will be assigned as normal mucosa, hyperplastic polyp, tubular adenoma, sessile serrated adenoma, or colorectal cancer.

Washington University School of Medicine

Optical Coherence Tomography (OCT) Probe

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Proportion of Participants Whose Procedure Length Using an OCT Probe During Routine Colonoscopy is Within 5 Minutes

Number of Participants With Adverse Events Related to OCT Imaging During Routine Colonoscopy

4 participants were excluded due to absence of polyps (n=1), probe malfunction (n=1), and poor image quality (n=2).

Number of Participants Who Have a Successfully Captured OCT Image Using Machine Learning Algorithm

Cohen's Weighted Kappa Score

Overall Study

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes.

A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.

Diagnostic Biopsy and Surgical Procedure

At the end of a standard MRI, we will perform IVIM, which is a diffusion-weighted imaging sequence that simultaneously characterizes the microscopic diffusivity of water and the macroscopic transport of water via bulk flow. IVIM may more accurately reflect the properties of the tumor microenvironment including vascular permeability, interstitial fluid pressure, and response to neoadjuvant therapy.

Intravoxel incoherent motion MRI (IVIM)

Following a standard MRI scan, Dynamic Contrast Enhanced MRI (DCE-MRI) will be done. DCE-MRI is an indicator-dilution experiment in which the delivery and transcapillary transfer of a contrast agent, typically one of a number of gadolinium-based contrast agents (GBCA), is used to assess a number of parameters characterizing tissue physiology. In locally advanced rectal cancer patients, use of DCE-MRI for determining pathologic response has produced equivocal results but more promising data has been published recently in the cervical cancer literature.

Dynamic Contrast Enhanced MRI (DCE-MRI)

RNA will be collected from biopsy and surgical tissue for gene expression analysis.

RNA gene expression analysis

Marka Crittenden, MD, PhD

This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.

The quality of the immune environment in colorectal cancer biopsy samples correlates with disease-free survival and overall survival more so than current staging conventions. This study will use a scoring system called 'immunoscore' to characterize the immune enviroment. Researchers hypothesize that the immunoscore will correlate with outcomes of colorectal patients treated with neoadjuvant chemoradiation.

Patients who enroll in the study will all undergo a biopsy as part of their standard of care evaluation. Biopsies samples will be obtained and sent to pathology for paraffin embedded blocks for diagnostic evaluation and for subsequent research. Patients will also have tissue stored in RNA later for subsequent microarray analysis.

Immunoscore in Rectal Cancer

A Study to Determine the Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy

This project is being done to contribute pathology samples and patient outcome data to a larger data set intended to validate an algorithm to predict patient outcome based on pathology data obtained at diagnosis. As part of this project, pre-existing samples will be used. There will be new slides made from the samples that will be stained to identify immune response. Pathology analysis and images of the slides will be provided (without patient identifiers) along with de-identified patient outcome data to a central coordinating center.

Quantitative immunohistochemical analysis will be performed on parameters of interest on both pre-treatment biopsy specimens as well as post-operative specimens. The pre-treatment sample will be used to establish the immunophenotype score. The primary analysis will evaluate the ability of immunophenotype score to correlate with pathologic response.

Oregon Health and Science University

Providence Health & Services

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Capecitabine

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folic Acid

Tetrahydrofolates

Formyltetrahydrofolates

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX

Radiation

Hyun Kim, M.D.

The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.

Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum

Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum (NORMAL-R)

* Criteria for complete clinical response:

  * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer
  * No radiographic evidence of tumor on DRE
  * Substantial downsizing on MRI
  * No suspicious mesorectal lymph nodes on MRI
  * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)
* Criteria for no significant clinical response:

  * Residual disease by DRE, endoscopy or MR.
  * Increase in primary tumor size upon clinical exam or imaging
  * Any new lesions

-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU

1 participant was not evaluable for this outcome measure as they were removed for an adverse event

Complete Response Rate

I have a lack of energy

I have nausea

Because of my physical condition, I have trouble meeting the needs of my family

I have pain

I am bothered by side effects of treatment

I feel ill

I am forced to spend time in bed

I feel close to my friends

I get emotional support from my family

I get support from my friends

My family has accepted my illness

I am satisfied with family communication about my illness

I feel close to my partner (or the person who is my main support)

I am satisfied with my sex life

I feel sad

I am satisfied with how I am coping with my illness

I am losing hope in the fight against my illness

I feel nervous

I worry about dying

I worry that my condition will get worse

I am able to work (include work at home)

My work (include work at home) is fulfilling

I am able to enjoy life

I have accepted my illness

I am sleeping well

I am enjoying the things I usually do for fun

I am content with the quality of my life right now

I have swelling or cramps in my stomach area

I am losing weight

I have control of my bowels

I can digest my food well

I have diarrhea (diarrhoea)

I have a good appetite

I like the appearance of my body

I am embarrassed by my ostomy appliance

Caring for my ostomy appliance is difficult

-Participant is asked about specific well-being in the past 7 days

0=Not at All

1=A Little Bit

2=Somewhat

3=Quite a Bit

4=Very Much

-Participant did not answer question about well-being

Prefer Not to Answer/No Answer/No

Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire

One participant was not evaluable for this outcome measure because they did not complete chemoradiation.

One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps	NCT05179837	Colon Cancer Rectal Cancer Cancer of the R... Cancer of the C... Precancerous Po... Malignant Polyp	Optical coheren...	40 Years -	Washington University School of Medicine
Immunoscore in Rectal Cancer	NCT02017509	Cancer of the R... Neoplasms, Rect... Rectal Cancer Rectal Tumors Rectal Adenocar...	Diagnostic Biop... Intravoxel inco... Dynamic Contras... RNA gene expres...	18 Years -	Providence Health & Services
Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum	NCT02641691	Cancer of Rectu... Cancer of the R... Neoplasm, Rectu... Rectal Cancer Rectum Cancer Rectum Neoplasm... Adenocarcinoma ...	Radiation Oxaliplatin Leucovorin Fluorouracil	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for cancer of the rectum