Tumor Cells and Tumor Markers in Peritoneal CavityCRCNCT02102074
Intra-peritoneal Environmental Changes Following Surgery
An observational study of Tumor Cells and Tumor Markers in Peritoneal Cavity, run by Meir Medical Center at 2 sites in Israel.
Trial summary
The investigators hypothesize that the presence of tumor cells and tumor markers in peritoneal cavity are indicative for peritoneal spread during surgery, and may serve as early markers for systemic and/or intra-peritoneal recurrence of the disease and ultimately improve our understanding of tumor spread and disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Cells and Tumor Markers in Peritoneal Cavity
- How many people
- 70 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2012to May 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: colon and rectal cancer patients
Who may be able to join
- colon and rectal cancer
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, Israel
Shmuel Avital, avitalshmuel@gmail.com
Liron Berkovich, Ph.D.
- Recruiting
Meir medical center
Kfar Saba, Israel
Shmuel Avital, M.D, avitalshmuel@gmail.com
Liron Berkovich, Ph.D.
About this study
Official title: Intra-peritoneal Environmental Changes Following Colorectal Surgery for Cancer
The investigators hypothesize that the presence of tumor cells and tumor markers in peritoneal cavity are indicative for peritoneal spread during surgery, and may serve as early markers for systemic and/or intra-peritoneal recurrence of the disease and ultimately improve our understanding of tumor spread and disease recurrence.
- Keywords
- colon and rectal tumors, colon cancer markers
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor cells and tumor markers
Measured: 2 years
Secondary outcomes (1)
Cytokine levels in the abdomen
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMay 2012
- Primary completionDec 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Cells and Tumor Markers in Peritoneal CavityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shmuel Avital, M.D., Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102074
- Sponsor's protocol ID
- 0036
- Acronym
- CRC
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2013
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-peritoneal Environmental Changes Following Colorectal Surgery for Cancer
- ClinicalTrials.gov ID
- NCT02102074
- Acronym / sponsor ID
- CRC / 0036
- Keywords
- colon and rectal tumors, colon cancer markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 2 Apr 2014 (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 investigators hypothesize that the presence of tumor cells and tumor markers in peritoneal cavity are indicative for peritoneal spread during surgery, and may serve as early markers for systemic and/or intra-peritoneal recurrence of the disease and ultimately improve our understanding of tumor spread and disease recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colon and rectal cancer patients
Key inclusion criteria (1 listed)
- colon and rectal cancer
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tumor cells and tumor markers
Time frame: 2 years
1 secondary outcome
Cytokine levels in the abdomen
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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.
Shmuel Avital, M.D. principal investigator
Meir Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor Cells and Tumor Markers in Peritoneal Cavity, run by Meir Medical Center at 2 sites in Israel.
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 1 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 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Shmuel Avital, M.D., Dr. (972-9-7472162 ext. 2162, avitalshmuel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor cells and tumor markers (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2014.