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CancerNCT05347524

Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study

An observational study of Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a prospective, multi-omics, observational study aimed at detecting peritoneal metastasis of gastric cancer by combined assays for methylation of cell-free DNA (cfDNA) and other blood-based biomarkers. The study will enroll 384 participants with gastric cancer. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Cancer
What is being tested?
Baseline blood draw and blood-based biomarkers analyses
How many people
384 participants
Where
1 siteChina
Study dates
1 Mar 2022to 30 Jun 2030
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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Eligible participants of gastric cancer without any types of tumor treatment will be recruited.

Who may be able to join

  • Age 18-74 years at the day of consenting to the study.
  • Able to provide a written informed consent.
  • No prior cancer treatment (local or systematic) with either of the following:
  • Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw.
  • High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.
  • Diagnosis of peritoneal metastasis by laparoscopy with cytology.
Show all 12Show fewer
  • Age 18-74 years at the day of consenting to the study.
  • Able to provide a written informed consent.
  • No prior cancer treatment (local or systematic) with either of the following:
  • Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw.
  • High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.
  • No peritoneal metastasis detected by laparoscopy with cytology.

Who cannot join

  • Insufficient qualified blood samples.
  • During pregnancy or lactation.
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
  • Recipient of blood transfusion within 7 days prior to blood draw.
  • Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
  • With other known malignant tumors or multiple primary tumors.
Show all 12Show fewer
  • Insufficient qualified blood samples.
  • During pregnancy or lactation.
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
  • Recipient of blood transfusion within 7 days prior to blood draw.
  • Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
  • With other known malignant tumors or multiple primary tumors.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yihong Sun, Ph. D contact

+86-021-65642662

sun.yihong@zs-hospital.sh.cn

Xuefei Wang, Ph. D contact

+86-021-65642662

wang.xuefei@zs-hospital.sh.cn

China1 site, 1 recruiting

  • ZhongShan Hospital, Fudan university, Shanghai, China

    Shanghai, Shanghai Municipality, 200032

    Yihong Sun, MD, 86-13701735406, sun.yihong@zs-hospital.sh.cn

    Yihong Sun, MD

    Recruiting

Other trials in China

About this study

This study is a prospective, multi-omics, observational study aimed at detecting peritoneal metastasis of gastric cancer by combined assays for methylation of cell-free DNA (cfDNA) and other blood-based biomarkers. The study will enroll 384 participants with gastric cancer.

Read the detailed description

Peritoneal metastasis (PM) in gastric cancer is associated with a poor prognosis.

Laparoscopy with cytology is performed to evaluate for peritoneal spread when considering chemoradiation or surgery. However, the laparoscopy is invasive and the sensitivity of computed tomography (CT) scan is poor for detecting PM. Therefore, it is necessary to evaluate the feasibility of cfDNA methylation and other blood-based biomarkers for the PM diagnosis.

The study will enroll 384 participants with gastric cancer. Baseline blood and diagnosis of PM by laparoscopy with cytology will be collected. Participants with PM will be defined as the case arm and participants without PM will be defined as the control arm. A PM diagnostic model will be developed.

Conditions
Cancer
Being tested
Baseline blood draw and blood-based biomarkers analyses
Keywords
stomach neoplasms, peritoneal metastasis, liquid biopsy, cell-free DNA (cfDNA) methylation
Medical subject headings
Neoplasms, Stomach Neoplasms

What participants receive

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

  • Baseline blood draw and blood-based biomarkers analysesOther

    Baseline blood draw and blood-based biomarkers analyses

Study groups in NCT05347524
Study groupRoleWhat they receive
Case arm - Gastric cancer with peritoneal metastasisBaseline blood samples will be collected from gastric cancer participants with peritoneal metastasis.
Receives: Other: Baseline blood draw and blood-based biomarkers analyses
Control arm - Gastric cancer without peritoneal metastasisBaseline blood samples will be collected from gastric cancer participants without peritoneal metastasis.
Receives: Other: Baseline blood draw and blood-based biomarkers analyses

What is being measured

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

  1. Sensitivity and specificity of the cfDNA methylation-based model in detecting peritoneal metastasis of gastric cancer.

    Measured: 30 months

  2. Sensitivity and specificity of a cfDNA methylation-based model, in combination with other biomarkers, for detecting peritoneal metastasis of gastric cancer.

    Measured: 30 months

Timeline

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

  1. First posted26 Apr 2022
  2. Study start1 Mar 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Jun 2030 (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
Other
Time perspective
Prospective
Enrolment
384 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05347524
Sponsor's protocol ID
B2022-081R
Status last verified
Apr 2022
First submitted
21 Apr 2022
Last updated
26 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • 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

  • Thomassen I, van Gestel YR, van Ramshorst B, Luyer MD, Bosscha K, Nienhuijs SW, Lemmens VE, de Hingh IH. Peritoneal carcinomatosis of gastric origin: a population-based study on incidence, survival and risk factors. Int J Cancer. 2014 Feb 1;134(3):622-8. doi: 10.1002/ijc.28373. Epub 2013 Aug 5.

    PubMed 23832847

  • Allen CJ, Newhook TE, Vreeland TJ, Das P, Minsky BD, Blum M, Song S, Ajani J, Ikoma N, Mansfield PF, Roy-Chowdhuri S, Badgwell BD. Yield of peritoneal cytology in staging patients with gastric and gastroesophageal cancer. J Surg Oncol. 2019 Dec;120(8):1350-1357. doi: 10.1002/jso.25729. Epub 2019 Oct 14.

    PubMed 31612494

  • Chen M, Zhao H. Next-generation sequencing in liquid biopsy: cancer screening and early detection. Hum Genomics. 2019 Aug 1;13(1):34. doi: 10.1186/s40246-019-0220-8.

    PubMed 31370908

  • Kinoshita J, Fushida S, Harada S, Makino I, Nakamura K, Oyama K, Fujita H, Ninomiya I, Fujimura T, Kayahara M, Ohta T. Type IV collagen levels are elevated in the serum of patients with peritoneal dissemination of gastric cancer. Oncol Lett. 2010 Nov;1(6):989-994. doi: 10.3892/ol.2010.181. Epub 2010 Sep 23.

    PubMed 22870099

  • So JBY, Kapoor R, Zhu F, Koh C, Zhou L, Zou R, Tang YC, Goo PCK, Rha SY, Chung HC, Yoong J, Yap CT, Rao J, Chia CK, Tsao S, Shabbir A, Lee J, Lam KP, Hartman M, Yong WP, Too HP, Yeoh KG. Development and validation of a serum microRNA biomarker panel for detecting gastric cancer in a high-risk population. Gut. 2021 May;70(5):829-837. doi: 10.1136/gutjnl-2020-322065. Epub 2020 Oct 7.

    PubMed 33028667

  • Shimura T, Toden S, Kandimalla R, Toiyama Y, Okugawa Y, Kanda M, Baba H, Kodera Y, Kusunoki M, Goel A. Genomewide Expression Profiling Identifies a Novel miRNA-based Signature for the Detection of Peritoneal Metastasis in Patients With Gastric Cancer. Ann Surg. 2021 Nov 1;274(5):e425-e434. doi: 10.1097/SLA.0000000000003647.

    PubMed 31663973

  • Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014 Jun;4(6):650-61. doi: 10.1158/2159-8290.CD-13-1014. Epub 2014 May 6.

    PubMed 24801577

  • Pantel K, Alix-Panabieres C. Liquid biopsy and minimal residual disease - latest advances and implications for cure. Nat Rev Clin Oncol. 2019 Jul;16(7):409-424. doi: 10.1038/s41571-019-0187-3.

    PubMed 30796368

  • Qi C, Li P, Hu Y, et al. The ctDNA in peritoneal effusion of advanced gastric cancer for auxiliary diagnosis of peritoneal metastasis. Journal of Clinical Oncology. 2019/05/20 2019;37(15_suppl):e15516-e15516. doi:10.1200/JCO.2019.37.15_suppl.e15516

  • Wu R, Li Q, Wu F, Shi C, Chen Q. Comprehensive Analysis of CDC27 Related to Peritoneal Metastasis by Whole Exome Sequencing in Gastric Cancer. Onco Targets Ther. 2020 Apr 21;13:3335-3346. doi: 10.2147/OTT.S244351. eCollection 2020.

    PubMed 32368092

  • Zhao D, Yue P, Wang T, Wang P, Song Q, Wang J, Jiao Y. Personalized analysis of minimal residual cancer cells in peritoneal lavage fluid predicts peritoneal dissemination of gastric cancer. J Hematol Oncol. 2021 Oct 12;14(1):164. doi: 10.1186/s13045-021-01175-2.

    PubMed 34641926

  • Klutstein M, Nejman D, Greenfield R, Cedar H. DNA Methylation in Cancer and Aging. Cancer Res. 2016 Jun 15;76(12):3446-50. doi: 10.1158/0008-5472.CAN-15-3278. Epub 2016 Jun 2.

    PubMed 27256564

  • Meng H, Cao Y, Qin J, Song X, Zhang Q, Shi Y, Cao L. DNA methylation, its mediators and genome integrity. Int J Biol Sci. 2015 Apr 8;11(5):604-17. doi: 10.7150/ijbs.11218. eCollection 2015.

    PubMed 25892967

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Shanghai Zhongshan Hospital at 1 site 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 12 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: looking for participants now, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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 Yihong Sun, Ph. D (+86-021-65642662, sun.yihong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and specificity of the cfDNA methylation-based model in detecting peritoneal metastasis of gastric cancer. (time frame: 30 months). 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 NCT05347524, which also lists 23 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 26 Apr 2022.

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