ClinicalTrials.gg
RecruitingNCT03432806Updated Oct 13, 2026

A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors

An observational study in Colon Cancer and Liver Tumors, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

From the registry’s dates

  • Started Nov 2017; still recruiting 8 years 11 months later.
Updated Oct 13, 2026Now RecruitingSite recruiting status changed+4 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 53 studies in Colonic Neoplasms by Memorial Sloan Kettering Cancer Center — 4 open to participants now, 9 under way, none of them phase 3. Colonic Neoplasms · Memorial Sloan Kettering Cancer Center.

Planned enrollment
7th of 14
80 · median 80
Started
2017
the only one that year
Observational
14 of 53
3 open now
Registered
50th of 53
by date

Among the 53 studies in Colonic Neoplasms by Memorial Sloan Kettering Cancer Center, this one is the 7th largest by planned enrollment of the 14 observational ones, is the only one that started in 2017, is one of 14 observational ones, and was the 50th registered.

By phase

53 studies; the count open now beside each. This study's row is marked.

Phase 116 · 0 open
Phase 215 · 1 open
Observationalthis study14 · 3 open
Phase 1/24 · 0 open
No phase3 · 0 open
Phase 31 · 0 open

By the year they started

First in 1981; this study’s year is marked. 1 started in 2017.

Size and results

Median enrollment 37 across the 24 interventional studies, 80 across the 14 observational. Of the 44 that completed or were terminated, 7 (16%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 53 studies in Colonic Neoplasms by Memorial Sloan Kettering Cancer Center, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Colon Cancer
  • Liver Tumors

Keywords

  • Tissue samples
  • 17-594
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

MSK clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Extrahepatic CRC
  • 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. 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 w/in 5 years (except non-melanomatous skin cancer)
  • Colon cancer with microsatellite instability (MSI-high) if known preoperatively
  • 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)
  • >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 (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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

Interventions

  • Otherblood draws

    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.

  • Procedurecolectomy or hepatectomy

    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.

  • Diagnostic testFibroscan test

    This may be done either at a preoperative clinic setting or immediately prior to surgery.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

07

Study locations

4 of 4 sites recruiting
  • Memorial Sloan Kettering Basking Ridge
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Michael D'Angelica, MD · Contact212-639-3226
  • Memorial Sloan Kettering Commack
    Commack, New York 11725, United States
    Recruiting
    • Michael D'Angelica, MD · Contact212-639-3226
  • Memorial Sloan Kettering Westchester
    Harrison, New York 10604, United States
    Recruiting
    • Michael D'Angelica, MD · Contact212-639-3226
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
    • Michael D'Angelica, MD · Contact212-639-3226
    • Martin Weiser, MD · Contact212-639-6698
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2017 (actual). Primary completion is estimated for Nov 2028, 132 months after the start.

Of 186 non-industry observational studies under Colonic Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's planned 132 months is above that.

Counting every sponsor, half of 224 studies reached it within 50 months; a quarter within 24 and three quarters within 116.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: primary completion Nov 2026 → Nov 2028 and completion Nov 2026 → Nov 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2018
First posted
Feb 14, 2018
StartActual
Nov 28, 2017
Primary completionEst.
Nov 2028was Nov 2026
CompletionEst.
Nov 2028was Nov 2026
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Recruiting
changed Oct 13, 2026
Sites
4 sites changed recruiting status (4 now recruiting)
Show 4 sites
  • Memorial Sloan Kettering Basking Ridge · Basking Ridge, United Statesno status→Recruiting
  • Memorial Sloan Kettering Commack · Commack, United Statesno status→Recruiting
  • Memorial Sloan Kettering Westchester · Harrison, United Statesno status→Recruiting
  • Memorial Sloan Kettering Cancer Center · New York, United Statesno status→Recruiting
Oct 13, 2026
Primary completion
Nov 2026→Nov 2028
Oct 13, 2026
Study completion
Nov 2026→Nov 2028
Oct 13, 2026
Enrollment
51 (actual)→80 (estimated)
Oct 13, 2026
Contact
Study contact now listed: added d•••@mskcc.org · •••3226; added •••6698. See the current contact
Oct 13, 2026
Site contacts
Changed at 4 sites. See the sites
Show 4 sites
  • Memorial Sloan Kettering Basking Ridge · Basking Ridge, United StatesContact added •••3226
  • Memorial Sloan Kettering Commack · Commack, United StatesContact added •••3226
  • Memorial Sloan Kettering Westchester · Harrison, United StatesContact added •••3226
  • Memorial Sloan Kettering Cancer Center · New York, United StatesContact added •••3226Contact added •••6698
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Active, not recruiting→Recruiting
    4 sites changed recruiting status (4 now recruiting)
    Show 4 sites
    • Memorial Sloan Kettering Basking Ridge · Basking Ridge, United Statesno status→Recruiting
    • Memorial Sloan Kettering Commack · Commack, United Statesno status→Recruiting
    • Memorial Sloan Kettering Westchester · Harrison, United Statesno status→Recruiting
    • Memorial Sloan Kettering Cancer Center · New York, United Statesno status→Recruiting
    Primary completion Nov 2026→Nov 2028
    Study completion Nov 2026→Nov 2028
    Enrollment 51 (actual)→80 (estimated)
    Contact Study contact now listed: added d•••@mskcc.org · •••3226; added •••6698. See the current contact
    Site contacts Changed at 4 sites. See the sites
    Show 4 sites
    • Memorial Sloan Kettering Basking Ridge · Basking Ridge, United StatesContact added •••3226
    • Memorial Sloan Kettering Commack · Commack, United StatesContact added •••3226
    • Memorial Sloan Kettering Westchester · Harrison, United StatesContact added •••3226
    • Memorial Sloan Kettering Cancer Center · New York, United StatesContact added •••3226Contact added •••6698
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03432806
Responsible party
Sponsor
First posted
Feb 14, 2018
Start date
Nov 28, 2017
Primary completion
Nov 2028 (estimated)
Completion
Nov 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Michael D'Angelica, MD
Contact
dangelim@mskcc.org
212-639-3226
Martin Wieser, MD
Contact
212-639-6698
Michael D'Angelica
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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