Cancer of the RectumNCT02017509
Immunoscore in Rectal Cancer
An observational study of Cancer of the Rectum and Neoplasms, Rectal, run by Providence Health & Services at 2 sites in United States.
Trial summary
This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Rectum, Neoplasms, Rectal, Rectal Cancer
- What is being tested?
- Diagnostic Biopsy and Surgical Procedure, Intravoxel incoherent motion MRI (IVIM) and Dynamic Contrast Enhanced MRI (DCE-MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jan 2014to 17 Jul 2018
- 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: Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum.
Who may be able to join
- Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum.
- Age > 18
- Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
Who cannot join
- History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
- Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence Health & Services
Portland, Oregon, 97213
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Study to Determine the Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy
This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.
Read the detailed description
The quality of the immune environment in colorectal cancer biopsy samples correlates with disease-free survival and overall survival more so than current staging conventions. This study will use a scoring system called 'immunoscore' to characterize the immune enviroment. Researchers hypothesize that the immunoscore will correlate with outcomes of colorectal patients treated with neoadjuvant chemoradiation.
- Conditions
- Cancer of the Rectum, Neoplasms, Rectal, Rectal Cancer, Rectal Tumors, Rectal Adenocarcinoma
- Being tested
- Diagnostic Biopsy and Surgical Procedure, Intravoxel incoherent motion MRI (IVIM), Dynamic Contrast Enhanced MRI (DCE-MRI), RNA gene expression analysis
- Keywords
- Immunophenotype, Immunoscore, MRI, RNA Later
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Biopsy and Surgical ProcedureProcedure or surgery
A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.
Intravoxel incoherent motion MRI (IVIM)Procedure or surgery
At the end of a standard MRI, we will perform IVIM, which is a diffusion-weighted imaging sequence that simultaneously characterizes the microscopic diffusivity of water and the macroscopic transport of water via bulk flow. IVIM may more accurately reflect the properties of the tumor microenvironment including vascular permeability, interstitial fluid pressure, and response to neoadjuvant therapy.
Dynamic Contrast Enhanced MRI (DCE-MRI)Procedure or surgery
Following a standard MRI scan, Dynamic Contrast Enhanced MRI (DCE-MRI) will be done. DCE-MRI is an indicator-dilution experiment in which the delivery and transcapillary transfer of a contrast agent, typically one of a number of gadolinium-based contrast agents (GBCA), is used to assess a number of parameters characterizing tissue physiology. In locally advanced rectal cancer patients, use of DCE-MRI for determining pathologic response has produced equivocal results but more promising data has been published recently in the cervical cancer literature.
RNA gene expression analysisGenetic
RNA will be collected from biopsy and surgical tissue for gene expression analysis.
| Study group | Role | What they receive |
|---|---|---|
| Rectal Cancer Patients | Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes. Receives: Procedure: Diagnostic Biopsy and Surgical Procedure; Procedure: Intravoxel incoherent motion MRI (IVIM); Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI); Genetic: RNA gene expression analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the number of infiltrating leukocytes within a biopsy sample with pathologic response
Quantitative immunohistochemical analysis will be performed on parameters of interest on both pre-treatment biopsy specimens as well as post-operative specimens. The pre-treatment sample will be used to establish the immunophenotype score. The primary analysis will evaluate the ability of immunophenotype score to correlate with pathologic response.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study start24 Jan 2014
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the RectumStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Marka Crittenden, MD, PhD, Principal investigator, Earle A. Chiles Research Institute at Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017509
- Sponsor's protocol ID
- 13-107A
- Status last verified
- Aug 2018
- First submitted
- 9 Dec 2013
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: This project is being done to contribute pathology samples and patient outcome data to a larger data set intended to validate an algorithm to predict patient outcome based on pathology data obtained at diagnosis. As part of this project, pre-existing samples will be used. There will be new slides made from the samples that will be stained to identify immune response. Pathology analysis and images of the slides will be provided (without patient identifiers) along with de-identified patient outcome data to a central coordinating center.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02017509
- Acronym / sponsor ID
- 13-107A
- Conditions
- Cancer of the Rectum, Neoplasms, Rectal, Rectal Cancer, Rectal Tumors, Rectal Adenocarcinoma
- Keywords
- Immunophenotype, Immunoscore, MRI, RNA Later
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 24 Jan 2014 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 20 Dec 2013 (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.
This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.
Detailed description
The quality of the immune environment in colorectal cancer biopsy samples correlates with disease-free survival and overall survival more so than current staging conventions. This study will use a scoring system called 'immunoscore' to characterize the immune enviroment. Researchers hypothesize that the immunoscore will correlate with outcomes of colorectal patients treated with neoadjuvant chemoradiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal Cancer Patients | – | Procedure: Diagnostic Biopsy and Surgical Procedure, Procedure: Intravoxel incoherent motion MRI (IVIM), Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI), Genetic: RNA gene expression analysisPatients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum.
Key inclusion criteria (3 listed)
- Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum.
- Age > 18
- Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
Key exclusion criteria (2 listed)
- History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
- Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
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 |
|---|---|---|
| Diagnostic Biopsy and Surgical ProcedureA tumor sample from the diagnostic biopsy and surgical procedure will be used for research. | Procedure or surgery | Rectal Cancer Patients |
| Intravoxel incoherent motion MRI (IVIM)At the end of a standard MRI, we will perform IVIM, which is a diffusion-weighted imaging sequence that simultaneously characterizes the microscopic diffusivity of water and the macroscopic transport of water via bulk flow. IVIM may more accurately reflect the properties of the tumor microenvironment including vascular permeability, interstitial fluid pressure, and response to neoadjuvant therapy. | Procedure or surgery | Rectal Cancer Patients |
| Dynamic Contrast Enhanced MRI (DCE-MRI)Following a standard MRI scan, Dynamic Contrast Enhanced MRI (DCE-MRI) will be done. DCE-MRI is an indicator-dilution experiment in which the delivery and transcapillary transfer of a contrast agent, typically one of a number of gadolinium-based contrast agents (GBCA), is used to assess a number of parameters characterizing tissue physiology. In locally advanced rectal cancer patients, use of DCE-MRI for determining pathologic response has produced equivocal results but more promising data has been published recently in the cervical cancer literature. | Procedure or surgery | Rectal Cancer Patients |
| RNA gene expression analysisRNA will be collected from biopsy and surgical tissue for gene expression analysis. | Genetic | Rectal Cancer Patients |
Primary outcome
Correlation of the number of infiltrating leukocytes within a biopsy sample with pathologic response
Time frame: 16 weeks
Quantitative immunohistochemical analysis will be performed on parameters of interest on both pre-treatment biopsy specimens as well as post-operative specimens. The pre-treatment sample will be used to establish the immunophenotype score. The primary analysis will evaluate the ability of immunophenotype score to correlate with pathologic response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Providence Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This project is being done to contribute pathology samples and patient outcome data to a larger data set intended to validate an algorithm to predict patient outcome based on pathology data obtained at diagnosis. As part of this project, pre-existing samples will be used. There will be new slides made from the samples that will be stained to identify immune response. Pathology analysis and images of the slides will be provided (without patient identifiers) along with de-identified patient outcome data to a central coordinating center.
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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.
Marka Crittenden, MD, PhD principal investigator
Earle A. Chiles Research Institute at Providence Health & Services
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 Cancer of the Rectum and Neoplasms, Rectal, run by Providence Health & Services at 2 sites in United States.
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 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: finished, as of the sponsor's last update on 29 Aug 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of the number of infiltrating leukocytes within a biopsy sample with pathologic response (time frame: 16 weeks). 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 29 Aug 2018.