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Gastric CancerDESTINEXNCT06342427

Stomach Cancer Exosome-based Detection

An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by City of Hope Medical Center at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
DESTINEX
How many people
809 participants
Where
3 sitesin 2 countries
Study dates
15 Mar 2023to 15 Jun 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Two cohorts of individuals with and without gastric cancer (cases and controls, respectively)

Who may be able to join

  • Histological diagnosis of stage I, II, III, IV gastric cancer (TNM classification, 8th edition) (cases).
  • Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
  • Confirmed cancer-free status at the time of study inclusion (Non-disease controls).

Who cannot join

  • Lack of written informed consent.
  • Systemic therapy before sampling.
  • Synchronous gastric and non-gastric cancer diagnosed at or before surgery.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Japan2 sites

  • Nagoya University

    Nagoya

  • Mie University

    Tsu

Other trials in Japan

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Early Detection of Stomach Cancer With a Liquid Biopsy Based on Exosomal Micro-RNA

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.

Read the detailed description

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. Because conventional endoscopy is invasive and costly, gastric cancer is currently not considered to be screenable at a population level. However, if one could find less invasive and cheaper tools that accurately detect gastric cancer in its early stages, it could make a significant difference. Accurate biomarkers could help identify patients with gastric cancer before it becomes incurable.

This study aims to develop a non-invasive test to detect gastric cancer early. It consists of four phases:

  1. Discovering potential biomarkers with a comprehensive and genome-wide transcriptomic sequencing analysis that will involve gastric cancer tissue, normal tissue, and serum samples from patients with gastric cancer, as well as samples from people without the disease.
  2. Using machine learning to develop a combination "signature" of cell-free (cf) and exosomal (exo)-miRNA in serum specimens from a training cohort.
  3. A validation of this signature in an independent cohort to confirm its accuracy.
  4. An evaluation of the temporal trend of this signature in paired samples collected pre-surgery and post-surgery to investigate their potential and specificity as indicators of minimal residual disease.

In summary, this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early. Success could lead to significant improvements in clinical practice by catching cancer when it is most treatable. By combining different genetic markers (cell-free microRNA and exosomal microRNA) for accuracy, this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future.

Being tested
DESTINEX
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • DESTINEXDiagnostic test

    Also called DESTINEX (DEtection of STomach NEoplasia in circulating eXosomes)

    A panel of microRNA, whose expression level is tested in serum samples.

Study groups in NCT06342427
Study groupRoleWhat they receive
Patients with Gastric Cancer (Training)Individuals with a pathologically confirmed diagnosis of gastric cancer
Receives: Diagnostic Test: DESTINEX
Patients without Gastric Cancer (Training)Individuals without cancer at the time of blood sampling
Receives: Diagnostic Test: DESTINEX
Patients with Gastric Cancer (Validation)Individuals with a pathologically confirmed diagnosis of gastric cancer
Receives: Diagnostic Test: DESTINEX
Patients without Gastric Cancer (Validation)Individuals without cancer at the time of blood sampling
Receives: Diagnostic Test: DESTINEX

What is being measured

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

  1. Sensitivity

    True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

    Measured: Through study completion, an average of 1 year

Secondary outcomes (2)

  1. Specificity

    True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

    Measured: Through study completion, an average of 1 year

  2. Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)

    A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted2 Apr 2024
  2. Study start15 Mar 2023
  3. Primary completion15 Jun 2024
  4. Study completion15 Jun 2024

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
Case-control
Time perspective
Retrospective
Enrolment
809 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342427
Sponsor's protocol ID
23228/DESTINEX
Acronym
DESTINEX
Status last verified
Jul 2024
First submitted
26 Mar 2024
Last updated
8 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

Publications

  • Smyth EC, Nilsson M, Grabsch HI, van Grieken NC, Lordick F. Gastric cancer. Lancet. 2020 Aug 29;396(10251):635-648. doi: 10.1016/S0140-6736(20)31288-5.

    PubMed 32861308

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Nishiwada S, Cui Y, Sho M, Jun E, Akahori T, Nakamura K, Sonohara F, Yamada S, Fujii T, Han IW, Tsai S, Kodera Y, Park JO, Von Hoff D, Kim SC, Li W, Goel A. Transcriptomic Profiling Identifies an Exosomal microRNA Signature for Predicting Recurrence Following Surgery in Patients With Pancreatic Ductal Adenocarcinoma. Ann Surg. 2022 Dec 1;276(6):e876-e885. doi: 10.1097/SLA.0000000000004993. Epub 2021 Jun 16.

    PubMed 34132691

  • Pasechnikov V, Chukov S, Fedorov E, Kikuste I, Leja M. Gastric cancer: prevention, screening and early diagnosis. World J Gastroenterol. 2014 Oct 14;20(38):13842-62. doi: 10.3748/wjg.v20.i38.13842.

    PubMed 25320521

  • Lee JH, Kim JG, Jung HK, Kim JH, Jeong WK, Jeon TJ, Kim JM, Kim YI, Ryu KW, Kong SH, Kim HI, Jung HY, Kim YS, Zang DY, Cho JY, Park JO, Lim DH, Jung ES, Ahn HS, Kim HJ. Clinical practice guidelines for gastric cancer in Korea: an evidence-based approach. J Gastric Cancer. 2014 Jun;14(2):87-104. doi: 10.5230/jgc.2014.14.2.87. Epub 2014 Jun 30.

    PubMed 25061536

  • Shimada H, Noie T, Ohashi M, Oba K, Takahashi Y. Clinical significance of serum tumor markers for gastric cancer: a systematic review of literature by the Task Force of the Japanese Gastric Cancer Association. Gastric Cancer. 2014 Jan;17(1):26-33. doi: 10.1007/s10120-013-0259-5. Epub 2013 Apr 10.

    PubMed 23572188

  • Heitzer E, Haque IS, Roberts CES, Speicher MR. Current and future perspectives of liquid biopsies in genomics-driven oncology. Nat Rev Genet. 2019 Feb;20(2):71-88. doi: 10.1038/s41576-018-0071-5.

    PubMed 30410101

  • Siravegna G, Mussolin B, Venesio T, Marsoni S, Seoane J, Dive C, Papadopoulos N, Kopetz S, Corcoran RB, Siu LL, Bardelli A. How liquid biopsies can change clinical practice in oncology. Ann Oncol. 2019 Oct 1;30(10):1580-1590. doi: 10.1093/annonc/mdz227.

    PubMed 31373349

  • Jung G, Hernandez-Illan E, Moreira L, Balaguer F, Goel A. Epigenetics of colorectal cancer: biomarker and therapeutic potential. Nat Rev Gastroenterol Hepatol. 2020 Feb;17(2):111-130. doi: 10.1038/s41575-019-0230-y. Epub 2020 Jan 3.

    PubMed 31900466

  • Rupaimoole R, Slack FJ. MicroRNA therapeutics: towards a new era for the management of cancer and other diseases. Nat Rev Drug Discov. 2017 Mar;16(3):203-222. doi: 10.1038/nrd.2016.246. Epub 2017 Feb 17.

    PubMed 28209991

  • Schwarzenbach H, Nishida N, Calin GA, Pantel K. Clinical relevance of circulating cell-free microRNAs in cancer. Nat Rev Clin Oncol. 2014 Mar;11(3):145-56. doi: 10.1038/nrclinonc.2014.5. Epub 2014 Feb 4.

    PubMed 24492836

  • Shigeyasu K, Toden S, Zumwalt TJ, Okugawa Y, Goel A. Emerging Role of MicroRNAs as Liquid Biopsy Biomarkers in Gastrointestinal Cancers. Clin Cancer Res. 2017 May 15;23(10):2391-2399. doi: 10.1158/1078-0432.CCR-16-1676. Epub 2017 Jan 31.

    PubMed 28143873

  • Toiyama Y, Okugawa Y, Goel A. DNA methylation and microRNA biomarkers for noninvasive detection of gastric and colorectal cancer. Biochem Biophys Res Commun. 2014 Dec 5;455(1-2):43-57. doi: 10.1016/j.bbrc.2014.08.001. Epub 2014 Aug 13.

    PubMed 25128828

  • Okugawa Y, Grady WM, Goel A. Epigenetic Alterations in Colorectal Cancer: Emerging Biomarkers. Gastroenterology. 2015 Oct;149(5):1204-1225.e12. doi: 10.1053/j.gastro.2015.07.011. Epub 2015 Jul 26.

    PubMed 26216839

  • Nik Mohamed Kamal NNSB, Shahidan WNS. Non-Exosomal and Exosomal Circulatory MicroRNAs: Which Are More Valid as Biomarkers? Front Pharmacol. 2020 Jan 20;10:1500. doi: 10.3389/fphar.2019.01500. eCollection 2019.

    PubMed 32038230

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by City of Hope Medical Center at 3 sites in 2 countries.

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 3 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: finished, as of the sponsor's last update on 8 Jul 2024. 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 Japan, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: Through study completion, an average of 1 year). 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 NCT06342427, which also lists 24 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 8 Jul 2024.

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Stomach Cancer Exosome-based Detection (NCT06342427) | AzTrials