Strigolactones and Dysplastic Colonic Lesions or Cancer

• Sponsor: Meir Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02824835
• Collaborator: (none)
• Enrollment: 150
• Duration (Months): 17

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of the plant hormones strigolactones, on cell cultures of colonic polyps and colorectal cancer.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms; Colonic Polyps	Procedure: biopsy during colonoscopy

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 Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Effect of the Plant Hormones Strigolactones on Cultures of Dysplastic Colonic Lesions and Cancer
• Study Start Date: Jul 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
adenoma group Patients with adenoma. Biopsies are taken before endoscopic resection.	Procedure: biopsy during colonoscopy; sampling the lesion with forcept biopter
cancer group Patients with colorectal cancer. Biopsies are taken before surgical resection.	Procedure: biopsy during colonoscopy; sampling the lesion with forcept biopter

Outcome Measures

Primary Outcome Measures

1. percentage of cells with reduced viability after dose-dependent exposure [24 hours of exposure to strigolactone]

2. percentage of cells in G2/M arrest after dose-dependent exposure [24 hours of exposure to strigolactone]

   analysis of cell cycle

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients with positive findings during colonoscopy

Exclusion Criteria:

• Patients below 18 years old

• Patients who cannot sign a consent form

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Meir Medical Center

Investigators

• Principal Investigator: Ido Laish, MD, Meir Medical Center

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: ido laish, MD, Meir Medical Center
• ClinicalTrials.gov Identifier: NCT02824835
• Other Study ID Numbers: IDO123
• First Posted: Jul 7, 2016
• Last Update Posted: Jul 7, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Colonic Neoplasms; Colonic Polyps

Study Results

No Results Posted as of Jul 7, 2016