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Strigolactones and Dysplastic Colonic Lesions or Cancer

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ClinicalTrials.gov Identifier: NCT02824835
Recruitment Status : Unknown
Verified July 2016 by ido laish, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
ido laish, Meir Medical Center

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
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.

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Study Type : Observational
Estimated 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 : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps

Group/Cohort 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




Primary Outcome Measures :
  1. percentage of cells with reduced viability after dose-dependent exposure [ Time Frame: 24 hours of exposure to strigolactone ]
  2. percentage of cells in G2/M arrest after dose-dependent exposure [ Time Frame: 24 hours of exposure to strigolactone ]
    analysis of cell cycle



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing colonoscopy who have positive findings (polyps, cancer) during the procedure
Criteria

Inclusion Criteria:

  • Patients with positive findings during colonoscopy

Exclusion Criteria:

  • Patients below 18 years old
  • Patients who cannot sign a consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824835


Contacts
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Contact: Ido Laish, MD + 972-9-7473261 ido.lish@clalit.org.il

Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Ido Laish, MD Meir Medical Center
Publications:
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Responsible Party: ido laish, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02824835    
Other Study ID Numbers: IDO123
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases