NCT02824835

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

June 27, 2016

Last Update Submit

July 2, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • percentage of cells with reduced viability after dose-dependent exposure

    24 hours of exposure to strigolactone

  • percentage of cells in G2/M arrest after dose-dependent exposure

    analysis of cell cycle

    24 hours of exposure to strigolactone

Study Arms (2)

adenoma group

Patients with adenoma. Biopsies are taken before endoscopic resection.

Procedure: biopsy during colonoscopy

cancer group

Patients with colorectal cancer. Biopsies are taken before surgical resection.

Procedure: biopsy during colonoscopy

Interventions

sampling the lesion with forcept biopter

adenoma groupcancer group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing colonoscopy who have positive findings (polyps, cancer) during the procedure

You may qualify if:

  • Patients with positive findings during colonoscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 26192476BACKGROUND
  • 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.

    PMID: 22476848BACKGROUND

MeSH Terms

Conditions

Colonic NeoplasmsColonic Polyps

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ido Laish, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 7, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 7, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share