- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02824835
Strigolactones and Dysplastic Colonic Lesions or Cancer
July 2, 2016 updated by: ido laish, Meir Medical Center
The Effect of the Plant Hormones Strigolactones on Cultures of Dysplastic Colonic Lesions and Cancer
The purpose of this study is to determine the effects of the plant hormones strigolactones, on cell cultures of colonic polyps and colorectal cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Strigolactones have been shown to anti-proliferative and pro-apoptotic effects in cell cultures of breast and prostate origin, partially by down-regulation of cyclin B1 and induction of cell cycle arrest.
In this study the investigators intend to take biopsies from benign colonic polyps and cancer tissue, culture intestinal explants and generate immortalized primary cells as a platform to assess the effect of this plant hormone on cell viability, cell mobility, apoptosis and cytoskeleton modifications.
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing colonoscopy who have positive findings (polyps, cancer) during the procedure
Description
Inclusion Criteria:
- Patients with positive findings during colonoscopy
Exclusion Criteria:
- Patients below 18 years old
- Patients who cannot sign a consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
adenoma group
Patients with adenoma.
Biopsies are taken before endoscopic resection.
|
sampling the lesion with forcept biopter
|
|
cancer group
Patients with colorectal cancer.
Biopsies are taken before surgical resection.
|
sampling the lesion with forcept biopter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percentage of cells with reduced viability after dose-dependent exposure
Time Frame: 24 hours of exposure to strigolactone
|
24 hours of exposure to strigolactone
|
|
|
percentage of cells in G2/M arrest after dose-dependent exposure
Time Frame: 24 hours of exposure to strigolactone
|
analysis of cell cycle
|
24 hours of exposure to strigolactone
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ido Laish, MD, Meir Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mayzlish-Gati E, Laufer D, Grivas CF, Shaknof J, Sananes A, Bier A, Ben-Harosh S, Belausov E, Johnson MD, Artuso E, Levi O, Genin O, Prandi C, Khalaila I, Pines M, Yarden RI, Kapulnik Y, Koltai H. Strigolactone analogs act as new anti-cancer agents in inhibition of breast cancer in xenograft model. Cancer Biol Ther. 2015;16(11):1682-8. doi: 10.1080/15384047.2015.1070982. Epub 2015 Jul 20.
- Pollock CB, Koltai H, Kapulnik Y, Prandi C, Yarden RI. Strigolactones: a novel class of phytohormones that inhibit the growth and survival of breast cancer cells and breast cancer stem-like enriched mammosphere cells. Breast Cancer Res Treat. 2012 Aug;134(3):1041-55. doi: 10.1007/s10549-012-1992-x. Epub 2012 Mar 29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
June 27, 2016
First Submitted That Met QC Criteria
July 2, 2016
First Posted (Estimate)
July 7, 2016
Study Record Updates
Last Update Posted (Estimate)
July 7, 2016
Last Update Submitted That Met QC Criteria
July 2, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Intestinal Neoplasms
- Colorectal Neoplasms
- Polyps
- Intestinal Polyps
- Colonic Polyps
- Colonic Neoplasms
Other Study ID Numbers
- IDO123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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