Colorectal CancerNCT06710067
Urine Metabolites in the Diagnosis of Disease
An observational study of Colorectal Cancer and Small Intestinal Bacterial Overgrowth Syndrome (SIBO), run by Luventix, Inc. at 4 sites in United States.
Trial summary
The goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (GI) diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Crohn Disease
- How many people
- 1,250 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2024to Sep 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are recruited in the United States and/or internationally, with the following order of priority and preference: · 1. multi-center recruitment and eligibility screen at approximately 5-10 clinical sites, and/or 2. clinical research organization (CRO) recruitment and eligibility screen, which may include internationally recruited patients and/or 3. decentralized recruitment via social media sites directing to an online eligibility screen and/or 4. Biobank/biorepository sourced frozen samples
Who may be able to join
- Age ≥ 18 years of age at time of enrollment.
- Able and willing to provide a one-time urine sample and comply with all study procedures for the study.
- Able to understand the study procedures, able to provide consent to participate in the study, and willing to authorize release of relevant protected health information by consenting to a HIPAA medical release form.
Who cannot join
- Known to be pregnant.
- A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Unio Health Partners (Gastroenterology)
Encinitas, California, 92024
Sarah Marchetti, Practice Manager, 760-783-0441, sarah.marchetti@uniohp.com
Robert Goldklang, MD
- Recruiting
Digestive Health Associates
Santa Monica, California, 90404
La Juana, Study Coordinator, 310-829-6789, elle20124me@gmail.com
Rahul Dixit, MD
- Recruiting
Westside Gastro Care
Santa Monica, California, 90404
Jennifer, Patient Care Coordinator, 310-285-3005, execassistant@westsidegastrocare.com
David Yamini, MD
- Recruiting
Bass Medical Group (Gastroenterology)
Walnut Creek, California, 94598
Stephanie Saxton, Practice Manager, CMA, 925-329-3723, stephanie.saxton@bassmedicalgroup.com
Rishi Sharma, MD
About this study
Official title: Observational Study of Urine Metabolites in the Diagnosis of Disease
The goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (GI) diseases.
This research study intends to enroll participants across a range of demographics and GI disease states including colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn\'s disease, and Celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific GI disease.
Read more
The main questions it aims to answer are:
- Does the platform identify a disease signal within each disease cohort, compared to normal controls?
- How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?
- Conditions
- Colorectal Cancer, Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Crohn Disease, Celiac Disease
- Medical subject headings
- Colorectal Neoplasms, Crohn Disease, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Disease Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease signal detection
Disease signal detection quantification within each disease cohort, compared to normal controls.
Measured: From date of enrollment to the end of sample analysis, up to 100 weeks
Test performance measures
Sensitivity and specificity/false-positive rate
Measured: From date of enrollment to the end of sample analysis, up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Oct 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luventix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Spinosa, MD, PhD, Principal investigator, Luventix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710067
- Sponsor's protocol ID
- Luventix-001
- Other IDs
- 20242000
- Status last verified
- Nov 2024
- First submitted
- 27 Sep 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pasikanti KK, Ho PC, Chan EC. Gas chromatography/mass spectrometry in metabolic profiling of biological fluids. J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Aug 15;871(2):202-11. doi: 10.1016/j.jchromb.2008.04.033. Epub 2008 Apr 29.
PubMed 18479983Dinges SS, Hohm A, Vandergrift LA, Nowak J, Habbel P, Kaltashov IA, Cheng LL. Cancer metabolomic markers in urine: evidence, techniques and recommendations. Nat Rev Urol. 2019 Jun;16(6):339-362. doi: 10.1038/s41585-019-0185-3.
PubMed 31092915Wittmann BM, Stirdivant SM, Mitchell MW, Wulff JE, McDunn JE, Li Z, Dennis-Barrie A, Neri BP, Milburn MV, Lotan Y, Wolfert RL. Bladder cancer biomarker discovery using global metabolomic profiling of urine. PLoS One. 2014 Dec 26;9(12):e115870. doi: 10.1371/journal.pone.0115870. eCollection 2014.
PubMed 25541698Fan J, Hong J, Hu JD, Chen JL. Ion chromatography based urine amino Acid profiling applied for diagnosis of gastric cancer. Gastroenterol Res Pract. 2012;2012:474907. doi: 10.1155/2012/474907. Epub 2012 Jul 25.
PubMed 22888338Issaq HJ, Nativ O, Waybright T, Luke B, Veenstra TD, Issaq EJ, Kravstov A, Mullerad M. Detection of bladder cancer in human urine by metabolomic profiling using high performance liquid chromatography/mass spectrometry. J Urol. 2008 Jun;179(6):2422-6. doi: 10.1016/j.juro.2008.01.084. Epub 2008 Apr 23.
PubMed 18433783
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Urine Metabolites in the Diagnosis of Disease
- ClinicalTrials.gov ID
- NCT06710067
- Acronym / sponsor ID
- Luventix-001
- Conditions
- Colorectal Cancer, Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Crohn Disease, Celiac Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Luventix, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Nov 2024 (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 goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (GI) diseases.
This research study intends to enroll participants across a range of demographics and GI disease states including colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn\'s disease, and Celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific GI disease.
The main questions it aims to answer are:
- Does the platform identify a disease signal within each disease cohort, compared to normal controls?
- How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disease Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are recruited in the United States and/or internationally, with the following order of priority and preference: · 1. multi-center recruitment and eligibility screen at approximately 5-10 clinical sites, and/or 2. clinical research organization (CRO) recruitment and eligibility screen, which may include internationally recruited patients and/or 3. decentralized recruitment via social media sites directing to an online eligibility screen and/or 4. Biobank/biorepository sourced frozen samples
Key inclusion criteria (3 listed)
- Age ≥ 18 years of age at time of enrollment.
- Able and willing to provide a one-time urine sample and comply with all study procedures for the study.
- Able to understand the study procedures, able to provide consent to participate in the study, and willing to authorize release of relevant protected health information by consenting to a HIPAA medical release form.
Key exclusion criteria (2 listed)
- Known to be pregnant.
- A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease signal detection
Time frame: From date of enrollment to the end of sample analysis, up to 100 weeks
Disease signal detection quantification within each disease cohort, compared to normal controls.
Test performance measures
Time frame: From date of enrollment to the end of sample analysis, up to 100 weeks
Sensitivity and specificity/false-positive rate
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 Dec 2024.
- Background: PubMed 18479983Pasikanti KK, Ho PC, Chan EC. Gas chromatography/mass spectrometry in metabolic profiling of biological fluids. J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Aug 15;871(2):202-11. doi: 10.1016/j.jchromb.2008.04.033. Epub 2008 Apr 29.
- Background: PubMed 31092915Dinges SS, Hohm A, Vandergrift LA, Nowak J, Habbel P, Kaltashov IA, Cheng LL. Cancer metabolomic markers in urine: evidence, techniques and recommendations. Nat Rev Urol. 2019 Jun;16(6):339-362. doi: 10.1038/s41585-019-0185-3.
- Background: PubMed 25541698Wittmann BM, Stirdivant SM, Mitchell MW, Wulff JE, McDunn JE, Li Z, Dennis-Barrie A, Neri BP, Milburn MV, Lotan Y, Wolfert RL. Bladder cancer biomarker discovery using global metabolomic profiling of urine. PLoS One. 2014 Dec 26;9(12):e115870. doi: 10.1371/journal.pone.0115870. eCollection 2014.
- Background: PubMed 22888338Fan J, Hong J, Hu JD, Chen JL. Ion chromatography based urine amino Acid profiling applied for diagnosis of gastric cancer. Gastroenterol Res Pract. 2012;2012:474907. doi: 10.1155/2012/474907. Epub 2012 Jul 25.
- Background: PubMed 18433783Issaq HJ, Nativ O, Waybright T, Luke B, Veenstra TD, Issaq EJ, Kravstov A, Mullerad M. Detection of bladder cancer in human urine by metabolomic profiling using high performance liquid chromatography/mass spectrometry. J Urol. 2008 Jun;179(6):2422-6. doi: 10.1016/j.juro.2008.01.084. Epub 2008 Apr 23.
- Related InfoLink provided by the sponsor.
- 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.
John Spinosa, MD, PhD principal investigator
Luventix, Inc.
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 Colorectal Cancer and Small Intestinal Bacterial Overgrowth Syndrome (SIBO), run by Luventix, Inc. 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 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 Catherine Fine, MS, CGC (888-404-3143, research@luventix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease signal detection (time frame: From date of enrollment to the end of sample analysis, up to 100 weeks). 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?
On the ClinicalTrials.gov record for NCT06710067, which also lists 5 linked publications.
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 Dec 2024.