Colonic NeoplasmsNCT02824835
Strigolactones and Dysplastic Colonic Lesions or Cancer
An observational study of Colonic Neoplasms and Colonic Polyps, run by Meir Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms, Colonic Polyps
- What is being tested?
- biopsy during colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing colonoscopy who have positive findings (polyps, cancer) during the procedure
Who may be able to join
- Patients with positive findings during colonoscopy
Who cannot join
- Patients below 18 years old
- Patients who cannot sign a consent form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colonic Neoplasms, Colonic Polyps
- Being tested
- biopsy during colonoscopy
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy during colonoscopyProcedure or surgery
sampling the lesion with forcept biopter
| Study group | Role | What they receive |
|---|---|---|
| adenoma group | Patients with adenoma. Biopsies are taken before endoscopic resection. Receives: Procedure: biopsy during colonoscopy | |
| cancer group | Patients with colorectal cancer. Biopsies are taken before surgical resection. Receives: Procedure: biopsy during colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of cells with reduced viability after dose-dependent exposure
Measured: 24 hours of exposure to strigolactone
percentage of cells in G2/M arrest after dose-dependent exposure
analysis of cell cycle
Measured: 24 hours of exposure to strigolactone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ido laish, Meir Medical Center
- Investigators
- Ido Laish, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824835
- Sponsor's protocol ID
- IDO123
- Status last verified
- Jul 2016
- First submitted
- 27 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26192476Pollock 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.
PubMed 22476848
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Plant Hormones Strigolactones on Cultures of Dysplastic Colonic Lesions and Cancer
- ClinicalTrials.gov ID
- NCT02824835
- Acronym / sponsor ID
- IDO123
- Conditions
- Colonic Neoplasms, Colonic Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of the plant hormones strigolactones, on cell cultures of colonic polyps and colorectal cancer.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adenoma group | – | Procedure: biopsy during colonoscopyPatients with adenoma. Biopsies are taken before endoscopic resection. |
| cancer group | – | Procedure: biopsy during colonoscopyPatients with colorectal cancer. Biopsies are taken before surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colonoscopy who have positive findings (polyps, cancer) during the procedure
Key inclusion criteria (1 listed)
- Patients with positive findings during colonoscopy
Key exclusion criteria (2 listed)
- Patients below 18 years old
- Patients who cannot sign a consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy during colonoscopysampling the lesion with forcept biopter | Procedure or surgery | adenoma group, cancer group |
Primary outcome
percentage of cells with reduced viability after dose-dependent exposure
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Background: PubMed 26192476Mayzlish-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.
- Background: PubMed 22476848Pollock 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ido Laish, MD principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Neoplasms and Colonic Polyps, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ido Laish, MD (+ 972-9-7473261, ido.lish@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of cells with reduced viability after dose-dependent exposure (time frame: 24 hours of exposure to strigolactone). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02824835, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.