ClinicalTrials.gg
RecruitingNCT05410977Updated Aug 18, 2026

Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients

An observational study in Colorectal Carcinoma and Lynch Syndrome, sponsored by Mayo Clinic. Recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.

Primary conditionColorectal Neoplasms, Hereditary NonpolyposisRegistry: Colorectal NeoplasmsReclassifiedWhy we changed it
Registry
Colorectal Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Colorectal Neoplasms, Hereditary Nonpolyposis
Why
  1. The study's listed conditions name Colorectal Neoplasms, Hereditary Nonpolyposis, a narrower term within Colorectal Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 7 months later.

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Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
950
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 71 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United States — 20 open to participants now, 32 under way, 2 of them phase 3. Colorectal Neoplasms, Hereditary Nonpolyposis · United States.

Planned enrollment
7th of 29
950 · median 300
Started
2022
with 2 others
Observational
29 of 71
8 open now
Primary completion
2027-12
later than 14 of 31 live
Registered
55th of 71
by date

Among the 71 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United States, this one is the 7th largest by planned enrollment of the 29 observational ones that give a count, is one of 3 that started in 2022, is one of 29 observational ones, reaches primary completion later than 14 of the 31 other live ones, and was the 55th registered.

Colorectal Neoplasms, Hereditary Nonpolyposis

146 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 60 are open to participants now.

Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →

Open to participants now

20 of the 71 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 43 Colorectal Neoplasms, Hereditary Nonpolyposis studies recruiting now, 32 (74%) set no upper age limit and 4 (9%) stop at 75 or younger; 4 take children under 18; 16 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 71 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United States, or all of them as a file.
02

Study summary

This study collects blood and stool samples from patients with suspected or diagnosed Lynch syndrome to evaluate a deoxyribonucleic acid (DNA) screening technique for the detection of colorectal cancer in Lynch syndrome patients.

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine the sensitivity and specificity of the multitarget stool DNA (mt-sDNA) 2.0 test, for colorectal neoplasia in patients with Lynch syndrome.

SECONDARY OBJECTIVE:

I. Develop a biorepository of samples (stool and blood) from patients with Lynch syndrome and early onset colorectal cancer.

OUTLINE:

Patients undergo collection of blood and stool samples no more than 90 days prior to or between 7-90 days after standard of care colonoscopy or flexible sigmoidoscopy. Patients' medical records are also reviewed.

03

Conditions studied

  • Colorectal Carcinoma
  • Lynch Syndrome

Browse trials for

04

In context

Colorectal Neoplasms, Hereditary Nonpolyposis Reclassified

146 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 60 are open to participants now.

This study's planned enrollment of 950 is above the median of 400 across 66 observational studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.

Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Compared within Colorectal Neoplasms, Hereditary Nonpolyposis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Colorectal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

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

Study population

Adults diagnosed with Lynch syndrome or suspected Lynch syndrome or early onset colorectal cancer.

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 at least 18 years of age
  • Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or colorectal cancer (CRC) with suspected Lynch syndrome or individuals diagnosed with early onset CRC (\<55 years old)
  • Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection
  • Patient has agreed to participate and has signed the study consent form

Exclusion criteria

Exclusion Criteria:

  • Patient has known cancer (stage I-IV) within 5 years prior to current sample collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current sample collection
  • Patient has had any abdominal radiation therapy prior to current sample collection
  • Patient had therapy to the target (non-hyperplastic) lesion with intent to completely remove or debulk the lesion prior to sample collection [examples include snare polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), surgical resection, trans anal excision]
  • Patient has prior diagnosis of non-lynch hereditary colon cancer syndrome [familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL]
  • ADDITIONAL STOOL EXCLUSIONS:
  • Bowel prep \<7 days prior to stool collection
  • Oral or rectal contrast given within 7 days prior to stool collection
  • Presence of ileostomy
  • Enteral feeds or total parenteral nutrition (TPN)
  • Diagnosis of inflammatory bowel disease
06

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
950 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (biospecimen collection, record review)

    Patients undergo collection of blood and stool samples no more than 90 days prior to or between 7-90 days after standard of care colonoscopy or flexible sigmoidoscopy. Patients' medical records are also reviewed.

    Procedure: Biospecimen Collection · Other: Electronic Health Record Review

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood and stool samples

  • OtherElectronic Health Record Review

    Medical records reviewed

07

What researchers measure

Primary outcomes

  1. Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia

    Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine sensitivity of the mt-sDNA 2.0 test

    Time frame: Up to 4 years

  2. Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia

    Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine specificity of the mt-sDNA 2.0 test

    Time frame: Up to 4 years

08

Study locations

7 of 9 sites recruiting
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2022 (actual). Primary completion is estimated for Dec 2027, 69 months after the start.

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

Registered
Jun 6, 2022
First posted
Jun 8, 2022
StartActual
Mar 30, 2022
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Aug 18, 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.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05410977
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Jun 8, 2022
Start date
Mar 30, 2022
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

Rosalie Himle
Contact
LaMere.Rosalie@mayo.edu
507-266-5755
Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Niloy Jewel Samadder, M.D.
principal investigator · Mayo Clinic

Oversight

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

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