Strigolactones and Dysplastic Colonic Lesions or Cancer

Colonic Neoplasms Clinical Trial

Official title:

The Effect of the Plant Hormones Strigolactones on Cultures of Dysplastic Colonic Lesions and Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02824835
• Other study ID #: IDO123
• Status: Not yet recruiting
• Phase: N/A
• First received: June 27, 2016
• Last updated: July 2, 2016
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Meir Medical Center
• Contact: Ido Laish, MD
• Phone: + 972-9-7473261
• Email: ido.lish[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with positive findings during colonoscopy

Exclusion Criteria:

• Patients below 18 years old

• Patients who cannot sign a consent form

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colonic Polyps

Intervention

Procedure:
• biopsy during colonoscopy
sampling the lesion with forcept biopter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of cells with reduced viability after dose-dependent exposure		24 hours of exposure to strigolactone	No
Primary	percentage of cells in G2/M arrest after dose-dependent exposure	analysis of cell cycle	24 hours of exposure to strigolactone	No