Colorectal CancerCRC-DRAWNCT05551052
CRC Detection Reliable Assessment With Blood
An observational study of Colorectal Cancer and Adenomas Colon, run by New Day Diagnostics at 3 sites in United States.
Trial summary
The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Colorectal Cancer, Adenomas Colon, Colon Cancer
- What is being tested?
- Next-Gen CRC Screening Test
- How many people
- 196 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Sep 2022to 31 Dec 2027
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy
Who may be able to join
- Participant is 45 years of age or older at time of enrollment.
- Participant is at average risk for development of colorectal cancer (as defined by inclusion and exclusion criteria)
- Participant is able and willing to undergo a screening colonoscopy
- Participant is able and willing to sign informed consent and adhere to study requirements
- Participant is able to provide blood sample prior to colonoscopy (within 90 days of scheduled colonoscopy).
Who cannot join
- Previous personal history of CRC or precancerous lesions
- Positive result from non-invasive screening test within the associated recommended intervals:
- 2.1 Fecal occult blood test or fecal immunochemical test within the previous 12 months 2.2 Epi proColon test within the previous 12 months 2.3 FIT-DNA (Cologuard) test within the previous 36 months
- Diagnosed with condition associated with higher risk for colorectal cancer, such as:
- 3.1 Inflammatory bowel disease (IBD) 3.2 Chronic ulcerative colitis (CUC) 3.3 Crohn's disease 3.4 Familial adenomatous polyposis (FAP) 3.5 Familial history for colorectal cancer 3.5.1 One or more first-degree relatives diagnosed with CRC or adenomatous polyps before 60 years of age 3.5.2 Two or more first degree relatives diagnosed at any age with CRC
- Individuals with relevant familial (hereditary) cancer syndrome, such as:
Show all 12Show fewer
- 4.1 Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome) 4.2 Peutz-Jeghers Syndrome 4.3 MYH-Associated Polyposis (MAP) 4.4 Gardner's syndrome 4.5Turcot's (or Crail's) syndrome 4.6 Cowden's syndrome, 4.7Juvenile Polyposis 4.8 Cronkhite-Canada syndrome 4.9 Neurofibromatosis 4.10 Familial Hyperplastic Polyposis
- Diagnosed with chronic gastritis or cirrhosis
- Current diagnosis of any cancer, except non-melanoma skin cancer
- Overt rectal bleeding or bleeding hemorrhoids within previous 30 days
- A colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Gastro SB
Chula Vista, California, 91910
SDG Clinical Research
San Diego, California, 92103
Medical Associates Research Group
San Diego, California, 92123
About this study
Official title: Prospective, Multi-center Observational Study for the Clinical Validation of the Next Generation Test for Blood-based Screening of Colorectal Cancer
The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.
Read the detailed description
The CRC DRAW study is a prospective, multi-center, observational study to validate the Next-Gen CRC Screening test for the detection of CRC. The study will collect blood samples from average-risk participants scheduled for screening colonoscopies.
- Conditions
- Colorectal Cancer, Adenomas Colon, Colon Cancer, Rectal Cancer, Colon Neoplasm, Colon Lesion
- Being tested
- Next-Gen CRC Screening Test
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Colonic Diseases, Colonic Polyps, Polyps, Adenoma, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next-Gen CRC Screening TestDiagnostic test
The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC.
| Study group | Role | What they receive |
|---|---|---|
| Next-Gen CRC Screening Test | Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy Receives: Diagnostic Test: Next-Gen CRC Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for CRC of the Next-Gen CRC Screening Test
Clinical Performance
Measured: blood collection up to 90 days from colonoscopy
Specificity for CRC of the Next-Gen CRC Screening Test
Clinical Performance
Measured: blood collection up to 90 days from colonoscopy
Secondary outcomes (2)
Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test
Clinical Performance
Measured: blood collection up to 90 days from colonoscopy
Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test
Clinical Performance
Measured: blood collection up to 90 days from colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start8 Sep 2022
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Day Diagnostics
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551052
- Sponsor's protocol ID
- SPR0033P
- Acronym
- CRC-DRAW
- Status last verified
- May 2025
- First submitted
- 20 Sep 2022
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center Observational Study for the Clinical Validation of the Next Generation Test for Blood-based Screening of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05551052
- Acronym / sponsor ID
- CRC-DRAW / SPR0033P
- Conditions
- Colorectal Cancer, Adenomas Colon, Colon Cancer, Rectal Cancer, Colon Neoplasm, Colon Lesion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (actual)
- Lead sponsor
- New Day DiagnosticsResearch network
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Sep 2022 (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 CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.
Detailed description
The CRC DRAW study is a prospective, multi-center, observational study to validate the Next-Gen CRC Screening test for the detection of CRC. The study will collect blood samples from average-risk participants scheduled for screening colonoscopies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Next-Gen CRC Screening Test | – | Diagnostic Test: Next-Gen CRC Screening TestAdults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy
Key inclusion criteria (5 listed)
- Participant is 45 years of age or older at time of enrollment.
- Participant is at average risk for development of colorectal cancer (as defined by inclusion and exclusion criteria)
- Participant is able and willing to undergo a screening colonoscopy
- Participant is able and willing to sign informed consent and adhere to study requirements
- Participant is able to provide blood sample prior to colonoscopy (within 90 days of scheduled colonoscopy).
Key exclusion criteria (12 listed)
- Previous personal history of CRC or precancerous lesions
- Positive result from non-invasive screening test within the associated recommended intervals:
- 2.1 Fecal occult blood test or fecal immunochemical test within the previous 12 months 2.2 Epi proColon test within the previous 12 months 2.3 FIT-DNA (Cologuard) test within the previous 36 months
- Diagnosed with condition associated with higher risk for colorectal cancer, such as:
- 3.1 Inflammatory bowel disease (IBD) 3.2 Chronic ulcerative colitis (CUC) 3.3 Crohn's disease 3.4 Familial adenomatous polyposis (FAP) 3.5 Familial history for colorectal cancer 3.5.1 One or more first-degree relatives diagnosed with CRC or adenomatous polyps before 60 years of age 3.5.2 Two or more first degree relatives diagnosed at any age with CRC
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 |
|---|---|---|
| Next-Gen CRC Screening TestThe Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC. | Diagnostic test | Next-Gen CRC Screening Test |
Primary outcome
Sensitivity for CRC of the Next-Gen CRC Screening Test
Time frame: blood collection up to 90 days from colonoscopy
Clinical Performance
Specificity for CRC of the Next-Gen CRC Screening Test
Time frame: blood collection up to 90 days from colonoscopy
Clinical Performance
2 secondary outcomes
Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test
Time frame: blood collection up to 90 days from colonoscopy
Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test
Time frame: blood collection up to 90 days from colonoscopy
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 29 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Adenomas Colon, run by New Day Diagnostics at 3 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 12 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 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Sensitivity for CRC of the Next-Gen CRC Screening Test (time frame: blood collection up to 90 days from colonoscopy). The study lists 2 primary outcomes in all. 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 May 2025.