AzTrials
AzTrials

Colorectal AdenomaNCT05870696

the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening

An observational study of Colorectal Adenoma, run by Peking University Third Hospital at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is to Evaluate the diagnostic sensitivity of the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer. There are two steps in this study. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Colorectal Adenoma
What is being tested?
PrecogColo Dx test
Type of treatment
Injection or infusion
How many people
2,000 participants
Where
6 sitesChina
Study dates
30 Apr 2023to 27 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

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: Subjects 45 years of age and older who are eligible for colorectal cancer screening and scheduled for a screening colonoscopy. Approximately 2,000 subjects will be targeted for enrollment.

Who may be able to join

  • Subject is ≥ 45 years of age at the time of enrollment.
  • Subject presents for a screening colonoscopy.
  • Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
  • Subject is able and willing to sign informed consent.

Who cannot join

  • Patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy and targeted therapy.
  • Patients received antibiotics within 2 weeks.
  • Patients with indications of emergency surgery, including bleeding, obstruction and perforation.
  • Patients who are positive for Human Immunodeficiency Virus (HIV).
  • Patients with abnormal liver and kidney function.
  • Patients with the history of inflammatory bowel disease.
Show all 10Show fewer
  • Patients who had history of other malignancies.
  • Subject has a diagnosis or medical history of any of the following conditions:
  • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
  • Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")

Trial locations and contacts

6 sites in 1 country.

shigang ding, doctor contact

15611908241

dingshigang222@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Beijing Huaxin Hospital

    Beijing, Beijing Municipality, 100016

    yanli cheng, doctor

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

    wei pei, doctor

    Recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    shiyu du, doctor, 13911531937

    Recruiting

  • Aerospace Center Hospital

    Beijing, Beijing Municipality, 100049

    yuanmin zhu, doctor, 13811634389

    Recruiting

  • Beijing haidian hospital

    Beijing, Beijing Municipality, 100080

    yinyan guo, doctor

    Recruiting

  • Peking university third hospital

    Beijing, Beijing Municipality, 100191

    Ming Zu, doctor, 15210325676, zuming7777@qq.com

    shigang Ding, doctor, 15611908241, dingshigang222@163.com

    Recruiting

Other trials in China

About this study

Official title: Evaluation of the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening

This study is to Evaluate the diagnostic sensitivity of the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer. There are two steps in this study. Firstly, the diagnostic model is established based on tumor-specific and gut-microbiome related serum metabolites. Secondly, the sensitivity, specificity and accuracy of the diagnostic model is evaluated in detecting advanced adenoma and colorectal cancer stages in an independent multi-centered cohort.

Read the detailed description

Subjects aged >45 at average risk for development of CRC will be enrolled. Subjects will complete the PrecogColo Dx test, followed by completion of a screening colonoscopy. . Results from PrecogColo Dx test were compared to the results of an optical colonoscopic examination, and histopathological diagnosis of all significant lesions discovered during the colonoscopy, in order to determine the sensitivity for CRC and advanced adenoma, respectively, as well as determining specificity of non-advanced neoplasia individuals. Histopathological results from biopsied tissue or excised lesions were categorized based on the most clinically significant lesion present by a central pathologist.

Being tested
PrecogColo Dx test
Keywords
colorectal adenomas; colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrecogColo Dx testDiagnostic test

    the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer

Study groups in NCT05870696
Study groupRoleWhat they receive
negativenormal:no findings on colonoscopy hyperplastic polyps: inflammatory or hyperplastic polyps low-risk adenoma:1 or 2 adenoma(s), ≤10 mm in size, non-advanced
Receives: Diagnostic Test: PrecogColo Dx test
Positiveadvanced adenoma Advance adenoma, including the following subcategories: * Adenoma with carcinoma in situ/high grade dysplasia, any size * Adenoma, villous growth pattern (>25%), any size * Adenoma > 1.0 cm in size * Serrated lesion, > 1.0 cm in size early stage CRC: CRC stage I advanced stage CRC: CRC stage II-IV
Receives: Diagnostic Test: PrecogColo Dx test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Effectiveness Evaluations

    Lower bound of the 95% one-sided confidence interval of PrecogColo Dx Sensitivity for CRC was greater than 65%, and lower bound of the 95% one-sided confidence interval of PrecogColo Dx specificity for non-advanced neoplasia (including normal, non-adenomas polyps and low risk adenoma) was greater than 85%.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2023
  2. Study start30 Apr 2023
  3. Primary completion27 Feb 2024 (estimated)
  4. Study completion27 Feb 2024 (estimated)

Resources

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
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05870696
Sponsor's protocol ID
PekingUTH-ding36
Status last verified
Apr 2023
First submitted
12 May 2023
Last updated
23 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Vatandoost N, Ghanbari J, Mojaver M, Avan A, Ghayour-Mobarhan M, Nedaeinia R, Salehi R. Early detection of colorectal cancer: from conventional methods to novel biomarkers. J Cancer Res Clin Oncol. 2016 Feb;142(2):341-51. doi: 10.1007/s00432-015-1928-z. Epub 2015 Feb 17.

    PubMed 25687380

  • Doubeni CA, Corley DA, Quinn VP, Jensen CD, Zauber AG, Goodman M, Johnson JR, Mehta SJ, Becerra TA, Zhao WK, Schottinger J, Doria-Rose VP, Levin TR, Weiss NS, Fletcher RH. Effectiveness of screening colonoscopy in reducing the risk of death from right and left colon cancer: a large community-based study. Gut. 2018 Feb;67(2):291-298. doi: 10.1136/gutjnl-2016-312712. Epub 2016 Oct 12.

    PubMed 27733426

  • Niedermaier T, Balavarca Y, Brenner H. Stage-Specific Sensitivity of Fecal Immunochemical Tests for Detecting Colorectal Cancer: Systematic Review and Meta-Analysis. Am J Gastroenterol. 2020 Jan;115(1):56-69. doi: 10.14309/ajg.0000000000000465.

    PubMed 31850933

  • Janney A, Powrie F, Mann EH. Host-microbiota maladaptation in colorectal cancer. Nature. 2020 Sep;585(7826):509-517. doi: 10.1038/s41586-020-2729-3. Epub 2020 Sep 23.

    PubMed 32968260

  • Yachida S, Mizutani S, Shiroma H, Shiba S, Nakajima T, Sakamoto T, Watanabe H, Masuda K, Nishimoto Y, Kubo M, Hosoda F, Rokutan H, Matsumoto M, Takamaru H, Yamada M, Matsuda T, Iwasaki M, Yamaji T, Yachida T, Soga T, Kurokawa K, Toyoda A, Ogura Y, Hayashi T, Hatakeyama M, Nakagama H, Saito Y, Fukuda S, Shibata T, Yamada T. Metagenomic and metabolomic analyses reveal distinct stage-specific phenotypes of the gut microbiota in colorectal cancer. Nat Med. 2019 Jun;25(6):968-976. doi: 10.1038/s41591-019-0458-7. Epub 2019 Jun 6.

    PubMed 31171880

  • Chen F, Dai X, Zhou CC, Li KX, Zhang YJ, Lou XY, Zhu YM, Sun YL, Peng BX, Cui W. Integrated analysis of the faecal metagenome and serum metabolome reveals the role of gut microbiome-associated metabolites in the detection of colorectal cancer and adenoma. Gut. 2022 Jul;71(7):1315-1325. doi: 10.1136/gutjnl-2020-323476. Epub 2021 Aug 30.

    PubMed 34462336

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Adenoma, run by Peking University Third Hospital at 6 sites in China.

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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact shigang ding, doctor (15611908241, dingshigang222@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Evaluations (time frame: 2 weeks). 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 NCT05870696, which also lists 7 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 23 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in