Rectal CancerLARC-EXNCT02113384
Locally Advanced Rectal Cancer - Exfoliated Peritoneal Tumor Cells
An observational study of Rectal Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
During the course of tumor growth and possibly by manipulation during the surgical procedure, cells from rectal tumors may be shed into the peritoneal cavity. Such cells may give rise to local recurrence or contribute to the formation of metastatic disease, specifically in the form of peritoneal carcinomatosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Observational study.
- How many people
- 231 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Jan 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients scheduled for surgical removal of a primary locally advanced rectal tumor at the Radium Hospital.
Who may be able to join
- patients scheduled for surgical removal of a primary locally advanced rectal tumor at the Norwegian Radium Hospital.
- age > 18 years
- written informed consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study of Exfoliated Peritoneal Tumor Cells in Locally Advanced Rectal Cancer
During the course of tumor growth and possibly by manipulation during the surgical procedure, cells from rectal tumors may be shed into the peritoneal cavity. Such cells may give rise to local recurrence or contribute to the formation of metastatic disease, specifically in the form of peritoneal carcinomatosis. Detection of cancer cells in the peritoneal cavity at the time of surgery might therefore be of value for prediction of disease recurrence with subsequent prognostic implications for these patients. In this study the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC.
Read the detailed description
The investigators recently published a study investigating the incidence of exfoliated cancer cells in peritoneal lavage fluid after resection of locally advanced rectal cancer (LARC). DNA isolated from cells obtained by peritoneal lavage was analyzed by denaturing capillary electrophoresis with respect to mutations in hotspots of the K-RAS gene. This gene is mutated in 30% of rectal tumors. Exfoliated tumor cells (as assessed by the presence of mutated DNA) were found in lavage fluid from 19/237 of the patients, and the presence of tumor cells was associated with poor overall survival. Based on these encouraging results the investigators have designed a more comprehensive prospective study, using a novel, validated set of cancer specific DNA methylation - based biomarkers present in the vast majority of all colorectal tumors (sensitivity 94%, specificity 98%).Using these tumor cell associated biomarkers, the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC. Lavage will be performed prior to and after manipulation of the tumor to provide data regarding both spontaneous and iatrogenic tumor cell exfoliation and their respective contribution to patient outcome. If detection of exfoliated tumor cells is predictive of tumor recurrence, this would support an active approach to postoperative chemotherapy, possibly in the form of intraperitoneal chemotherapy.
- Conditions
- Rectal Cancer
- Being tested
- Observational study.
- Keywords
- Rectal cancer, Locally advanced rectal cancer, Peritoneal carcinomatosis, Exfoliated peritoneal cells, Peritoneal lavage
- Medical subject headings
- Rectal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study.Other
Also called Observational study. Laboratory biomarker analysis.
Biobanking of tissue (tumor biopsy, peritoneal lavage, blood specimen) from patients with locally advanced rectum cancer undergoing surgical resection of the primary tumor at the Norwegian Radium Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Observational study | Patients with locally advanced rectum cancer undergoing surgical resection of the primary tumor at the Norwegian Radium Hospital. Receives: Other: Observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from surgery until death from any cause
Measured: 5 years
Secondary outcomes (3)
Disease-free survival
Time from surgery until disease recurrence or death
Measured: 5 years
Disease-free survival
Time from surgery until disease recurrence or death
Measured: 3 years
Overall survival
Time from surgery until death from any cause
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startSep 2012
- Primary completionSep 2021 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 231 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Kjersti Flatmark, Oslo University Hospital
- Investigators
- Bjørn-Atle Bjørnbeth, MD PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113384
- Sponsor's protocol ID
- Larc-Ex_09/2012
- Acronym
- LARC-EX
- Status last verified
- Jul 2021
- First submitted
- 8 Apr 2014
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Exfoliated Peritoneal Tumor Cells in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT02113384
- Acronym / sponsor ID
- LARC-EX / Larc-Ex_09/2012
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Locally advanced rectal cancer, Peritoneal carcinomatosis, Exfoliated peritoneal cells, Peritoneal lavage
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Sep 2012 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 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.
During the course of tumor growth and possibly by manipulation during the surgical procedure, cells from rectal tumors may be shed into the peritoneal cavity. Such cells may give rise to local recurrence or contribute to the formation of metastatic disease, specifically in the form of peritoneal carcinomatosis. Detection of cancer cells in the peritoneal cavity at the time of surgery might therefore be of value for prediction of disease recurrence with subsequent prognostic implications for these patients. In this study the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC.
Detailed description
The investigators recently published a study investigating the incidence of exfoliated cancer cells in peritoneal lavage fluid after resection of locally advanced rectal cancer (LARC). DNA isolated from cells obtained by peritoneal lavage was analyzed by denaturing capillary electrophoresis with respect to mutations in hotspots of the K-RAS gene. This gene is mutated in 30% of rectal tumors. Exfoliated tumor cells (as assessed by the presence of mutated DNA) were found in lavage fluid from 19/237 of the patients, and the presence of tumor cells was associated with poor overall survival. Based on these encouraging results the investigators have designed a more comprehensive prospective study, using a novel, validated set of cancer specific DNA methylation - based biomarkers present in the vast majority of all colorectal tumors (sensitivity 94%, specificity 98%).Using these tumor cell associated biomarkers, the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC. Lavage will be performed prior to and after manipulation of the tumor to provide data regarding both spontaneous and iatrogenic tumor cell exfoliation and their respective contribution to patient outcome. If detection of exfoliated tumor cells is predictive of tumor recurrence, this would support an active approach to postoperative chemotherapy, possibly in the form of intraperitoneal chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational study | – | Other: Observational study.Patients with locally advanced rectum cancer undergoing surgical resection of the primary tumor at the Norwegian Radium Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgical removal of a primary locally advanced rectal tumor at the Radium Hospital.
Key inclusion criteria (3 listed)
- patients scheduled for surgical removal of a primary locally advanced rectal tumor at the Norwegian Radium Hospital.
- age > 18 years
- written informed consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Observational study.Also: Observational study. Laboratory biomarker analysis.Biobanking of tissue (tumor biopsy, peritoneal lavage, blood specimen) from patients with locally advanced rectum cancer undergoing surgical resection of the primary tumor at the Norwegian Radium Hospital. | Other | Observational study |
Primary outcome
Overall survival
Time frame: 5 years
Time from surgery until death from any cause
3 secondary outcomes
Disease-free survival
Time frame: 5 years
Disease-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
Bjørn-Atle Bjørnbeth, MD PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Oslo University Hospital at 1 site in Norway.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 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 28 Jul 2021.