Colon CancerNCT03432806
A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors
An observational study of Colon Cancer and Liver Tumors, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
The purpose of this study is to explore novel ways of diagnosing colon cancer and predicting its propensity to spread to other organs such as the liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Liver Tumors
- What is being tested?
- blood draws, colectomy or hepatectomy and Fibroscan test
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Nov 2017to Nov 2028
- 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: MSK clinic
Who may be able to join
- Patients must be undergoing one of the following procedures as part of their routine care in order to meet the inclusion criteria:
- Operation for presumed stage I-IV colon cancer including colectomy, hepatectomy, or abdominal surgery (e.g. insertion of HAIP)
- Colectomy for presumed benign or pre-malignant colon tumors (e.g. large nonneoplastic polyps or adenomas)
- Open, laparoscopic, or robotic resections
- ≥18 years old
Who cannot join
- Extrahepatic CRC metastasis
- No preoperative portal venous phase CT scan performed up to two months prior to day of surgery Pathology demonstrating a malignant tumor other than colorectal adenocarcinoma.
- Stage IV colon cancer with resectable hepatic disease undergoing hepatectomy with active primary colon tumor still in place (despite chemo-radiation therapy) and no plans for colectomy.
- Receipt of experimental therapies for colon cancer (e.g. checkpoint inhibitors or novel targeted agents). Of note, approved targeted agents (such as anti-angiogenic agents, EGFR inhibitors etc) are not an exclusion criterion.
- History of non-colonic malignancy w/in 5 years (except non-melanomatous skin cancer)
- Colon cancer with microsatellite instability (MSI-high) if known preoperatively
Show all 13Show fewer
- Known hereditary colon cancer syndrome such as familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
- Known liver disease (e.g. non-alcoholic steatohepatitis, cirrhosis, viral or other form of hepatitis, etc)
- INR >2 or known clotting factor deficiency
- Anticipated need for full anticoagulation during hospitalization
- Receipt of medications that increase significantly the risk of bleeding after liver biopsy (at the surgeon"s discretion)
- Intraoperative discovery of pathology that precludes the planned surgical resection or liver biopsy, or makes resection futile (such as peritoneal carcinomatosis or other extrahepatic metastatic disease)
- Operating surgeon deems research interventions to be more than a minimal risk for the patient
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Martin Wieser, MD contact
United States4 sites, 4 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Michael D'Angelica, MD, 212-639-3226
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Michael D'Angelica, MD, 212-639-3226
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Michael D'Angelica, MD, 212-639-3226
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Michael D'Angelica, MD, 212-639-3226
Martin Weiser, MD, 212-639-6698
About this study
Official title: Development of Novel Imaging and Laboratory Biomarkers to Monitor the Liver Pre-metastatic Niche and Guide Treatment of Colon Cancer: A Pilot Study
The purpose of this study is to explore novel ways of diagnosing colon cancer and predicting its propensity to spread to other organs such as the liver.
- Conditions
- Colon Cancer, Liver Tumors
- Being tested
- blood draws, colectomy or hepatectomy, Fibroscan test
- Keywords
- Tissue samples, 17-594
- Medical subject headings
- Colonic Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawsOther
Patients will have 10 mL of peripheral venous blood drawn immediately prior to surgery, in the post anesthesia care unit (PACU), and at the first postoperative clinic visit for a total of 30 mL.
colectomy or hepatectomyProcedure or surgery
Three small pieces of otherwise "normal-appearing" liver of 0.5-1 cm3 collected intraoperatively from patients in all four groups (including Group D). Because liver biopsy is less frequently performed during operations for benign colon lesions or Stage I-III colon cancers, this single aspect of the protocol can be made optional at the discretion of the surgical attending or the patient, however bloods and tissue from pathology will still be collected.
Fibroscan testDiagnostic test
This may be done either at a preoperative clinic setting or immediately prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| presumptive Stage II or III colon cancer | Not described Receives: Other: blood draws; Procedure: colectomy or hepatectomy; Diagnostic Test: Fibroscan test | |
| Stage IV colon cancer with resectable hepatic metastases | Not described Receives: Other: blood draws; Procedure: colectomy or hepatectomy; Diagnostic Test: Fibroscan test | |
| Stage IV colon cancer with unresectable hepatic metastases | Not described Receives: Other: blood draws; Procedure: colectomy or hepatectomy; Diagnostic Test: Fibroscan test | |
| Stage I colon cancer, pre-neoplastic or benign colon lesions | Not described Receives: Other: blood draws; Procedure: colectomy or hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful isolation of exosomes
defined as isolation of at least 5μg of exosomal protein and reported as a binomial proportion with a 95% confidence interval.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start28 Nov 2017
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Michael D'Angelica, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432806
- Sponsor's protocol ID
- 17-594
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel Imaging and Laboratory Biomarkers to Monitor the Liver Pre-metastatic Niche and Guide Treatment of Colon Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT03432806
- Acronym / sponsor ID
- 17-594
- Conditions
- Colon Cancer, Liver Tumors
- Keywords
- Tissue samples, 17-594
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 14 Feb 2018 (actual)
- 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 explore novel ways of diagnosing colon cancer and predicting its propensity to spread to other organs such as the liver.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| presumptive Stage II or III colon cancer | – | Other: blood draws, Procedure: colectomy or hepatectomy, Diagnostic Test: Fibroscan test |
| Stage IV colon cancer with resectable hepatic metastases | – | Other: blood draws, Procedure: colectomy or hepatectomy, Diagnostic Test: Fibroscan test |
| Stage IV colon cancer with unresectable hepatic metastases | – | Other: blood draws, Procedure: colectomy or hepatectomy, Diagnostic Test: Fibroscan test |
| Stage I colon cancer, pre-neoplastic or benign colon lesions | – | Other: blood draws, Procedure: colectomy or hepatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSK clinic
Key inclusion criteria (5 listed)
- Patients must be undergoing one of the following procedures as part of their routine care in order to meet the inclusion criteria:
- Open, laparoscopic, or robotic resections
- ≥18 years old
Key exclusion criteria (13 listed)
- Extrahepatic CRC metastasis
- No preoperative portal venous phase CT scan performed up to two months prior to day of surgery Pathology demonstrating a malignant tumor other than colorectal adenocarcinoma.
- Stage IV colon cancer with resectable hepatic disease undergoing hepatectomy with active primary colon tumor still in place (despite chemo-radiation therapy) and no plans for colectomy.
- Receipt of experimental therapies for colon cancer (e.g. checkpoint inhibitors or novel targeted agents). Of note, approved targeted agents (such as anti-angiogenic agents, EGFR inhibitors etc) are not an exclusion criterion.
- History of non-colonic malignancy w/in 5 years (except non-melanomatous skin cancer)
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 |
|---|---|---|
| blood drawsPatients will have 10 mL of peripheral venous blood drawn immediately prior to surgery, in the post anesthesia care unit (PACU), and at the first postoperative clinic visit for a total of 30 mL. | Other | Stage I colon cancer, pre-neoplastic or benign colon lesions, Stage IV colon cancer with resectable hepatic metastases, Stage IV colon cancer with unresectable hepatic metastases, presumptive Stage II or III colon cancer |
| colectomy or hepatectomyThree small pieces of otherwise "normal-appearing" liver of 0.5-1 cm3 collected intraoperatively from patients in all four groups (including Group D). Because liver biopsy is less frequently performed during operations for benign colon lesions or Stage I-III colon cancers, this single aspect of the protocol can be made optional at the discretion of the surgical attending or the patient, however bloods and tissue from pathology will still be collected. | Procedure or surgery | Stage I colon cancer, pre-neoplastic or benign colon lesions, Stage IV colon cancer with resectable hepatic metastases, Stage IV colon cancer with unresectable hepatic metastases, presumptive Stage II or III colon cancer |
| Fibroscan testThis may be done either at a preoperative clinic setting or immediately prior to surgery. | Diagnostic test | Stage IV colon cancer with resectable hepatic metastases, Stage IV colon cancer with unresectable hepatic metastases, presumptive Stage II or III colon cancer |
Primary outcome
successful isolation of exosomes
Time frame: 1 year
defined as isolation of at least 5μg of exosomal protein and reported as a binomial proportion with a 95% confidence interval.
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 13 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Martin Wieser, MD contact
Michael D'Angelica principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Liver Tumors, run by Memorial Sloan Kettering Cancer Center at 4 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Contact Michael D'Angelica, MD (212-639-3226, dangelim@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful isolation of exosomes (time frame: 1 year). 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 13 Oct 2026.