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Gastric CancerGCMDKDNCT05010863

Gastric Cancer Marker Detection and Its Kit Development

An observational study of Gastric Cancer, run by Second Affiliated Hospital of Wenzhou Medical University 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

The gastric cancer diagnosis and treatment specifications clearly point out that tumor markers need to be detected in the process of diagnosis, efficacy evaluation and follow-up. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Gastric Cancer
What is being tested?
Blood collection
How many people
530 participants
Where
1 siteChina
Study dates
1 Jan 2021to 30 Dec 2030
How long will I take part?
1 Day
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Patients from the Second Affiliated Hospital of Wenzhou Medical University, Yuying Children's Hospital, the First Affiliated Hospital of Wenzhou Medical University, and Taizhou Hospital, Zhejiang Province

Who may be able to join

  • patient
  • Age is greater than or equal to 18 years old (including 18 years old);
  • Patients who are diagnosed with cancer after pathological diagnosis;
  • Can provide enough tissue samples;
  • Have not received anti-tumor treatment in the past;
  • Comply with the principle of informed consent and sign the informed consent form.
Show all 11Show fewer
  • healthy person:
  • Age is greater than or equal to 18 years old (including 18 years old);
  • No underlying disease;
  • Can provide enough tissue samples;
  • Comply with the principle of informed consent and sign the informed consent form.

Who cannot join

  • The tumor foci cannot be clearly derived from a specific tumor type;
  • Those who have a history of other tumors, autoimmune diseases and allergies;
  • Previously received anti-tumor treatments such as surgery, chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, biological therapy or Chinese medicines with anti-cancer and anti-tumor effects in the instructions;
  • Participated in any clinical trial within 90 days before the experiment;
  • Received major surgery within 90 days before the experiment;
  • Received bone marrow transplantation 90 days before the experiment;
  • Subjects who may not be able to complete the study due to other reasons or who are determined by the investigator to be unsuitable to participate in this study.

Trial locations and contacts

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

Weijian Sun, PhD contact

13857772361

fame198288@126.com

China1 site, 1 recruiting

  • No. 109, Xueyuan West Road, Lucheng District, Wenzhou City，Zhejiang provincece

    Wenzhou, Zhejiang, 325000

    weijian Sun, PhD, 13857772361 ext. 85676870, fame198288@126.com

    Recruiting

Other trials in China

About this study

The gastric cancer diagnosis and treatment specifications clearly point out that tumor markers need to be detected in the process of diagnosis, efficacy evaluation and follow-up. However, there is currently a lack of gastric cancer markers with high sensitivity and specificity, and the detection of markers is limited to a single index analysis, which has many shortcomings such as long analysis time, large reagent consumption, and high detection cost. Therefore, this project will use protein chips to detect new types of gastric cancer patient markers and establish a multi-diagnostic model for early screening of gastric cancer. Finally, monoclonal antibodies will be produced against various high-specific tumor markers and a gastric cancer diagnostic kit will be established.

Read the detailed description

1 Preliminary screening of early gastric cancer markers and antibody verification

(1) Recruitment and sample preparation of patients and healthy people: This project requires four batches of subjects, three batches of healthy people, early gastric cancer and advanced gastric cancer groups, with an average of 30 cases in each group. The other batch (the second batch) is healthy people and 30 cases of chronic atrophic gastritis, early gastric cancer and 30 cases of chronic atrophic gastritis. There were 100 cases in each of the advanced gastric cancer group, and 20 cases in each of liver cancer, colorectal cancer, and breast cancer. Serum and plasma samples obtained from subjects are used to screen potential gastric cancer tumor markers, verify the practicability of established gastric cancer tumor marker diagnostic models and test kits.

  1. Recruitment of gastric cancer patients: 30 cases of early gastric cancer patients (T1, T2) and advanced gastric cancer patients (T3, T4) are selected respectively. The staging of gastric cancer is based on the eighth edition of UICC (International Union Against Cancer) TNM staging. Subjects were screened according to the requirements of the informed consent form.
  2. Recruitment of healthy people: 30 volunteers without underlying diseases are selected as healthy control group. Subjects were screened according to the requirements of the informed consent form.
  3. Sample preparation: intravenous collection to obtain whole blood samples of patients and healthy controls. The sample requirement for each subject is 600ul of serum and plasma. (2) Antibody chip screening for potential tumor markers of gastric cancer for the first time In order to screen for potential protein markers of gastric cancer, Raybiotech's high-throughput quantitative antibody chip (AAH-BLG-2000) was used to measure 640 in the first batch of subjects (early gastric cancer, advanced gastric cancer, and healthy controls each 30). Kind of human protein. Preliminarily screen out differential proteins, conduct bioinformatics analysis, and finally screen differentially expressed proteins relevant to the research.

2Customized antibody chip to verify gastric cancer tumor markers In order to further verify the candidate tumor markers for the diagnosis of gastric cancer, the differential proteins screened in the previous stage were customized for antibody chips. Use subject serum samples (second batch) for potential biomarker verification. According to the test results, the poorly specific proteins are discarded, and the more specific proteins are retained.

  1. Establishment of diagnostic model Use regression analysis to combine and compare multiple differential proteins, perform quantitative analysis, establish a standard curve, establish a diagnostic model for highly specific differential proteins, and further measure the practicability of the highly specific differential protein diagnostic model.

4 Kit development Monoclonal antibodies were produced as capture antibodies for various high-specific tumor markers, and finally a gastric cancer diagnosis kit was established and promoted in clinical practice.

Establishment and performance measurement of gastric cancer diagnostic kit.

  1. Establish gastric cancer diagnostic kits, quality control reference materials and formulate relevant standards on the basis of the above research results.
  2. Precision testing: Dilute the self-made quality control reference materials to 3 concentrations of high, medium, and low, each with 3 replicate holes, repeat the test 10 times, and calculate the mean, standard deviation, and test value of each quality control reference product. Coefficient of Variation (CV) value.
  3. Sensitivity detection: Take the zero reference standard (specific difference protein) as the sample, and substitute the average value of the fluorescence value measured 20 times plus 2 times the standard deviation into the standard curve equation to calculate the minimum detection volume.
  4. Stability test: Divide the self-made kits into two groups and place them in a 4℃ freezer for 6 months and 37℃ for 7 days. The physical appearance of the kit, the linearity of the dose-response curve, accuracy, sensitivity, and minimum detection volume And other indicators are measured, and the specific detection method is the same as the above steps (2) and (3).
  5. Comparison with other gastric cancer detection methods: use self-prepared detection kits to detect 30 cases of early gastric cancer serum samples, 30 cases of advanced gastric cancer serum samples, and 30 healthy human serum samples, and analyze the test results.
  6. Promotion and optimization of the kit. Random sampling is performed among patients using this kit to observe the diagnosis rate of early clinical gastric cancer and the corresponding prognosis, and analyze the results of the return visit. According to the results of the return visit, continue to conduct corresponding experiments to optimize the performance of the kit, for example: improve its accuracy, sensitivity, and so on.
Conditions
Gastric Cancer
Being tested
Blood collection
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Blood collectionOther

    The subject will be drawn a 5ml blood sample

Study groups in NCT05010863
Study groupRoleWhat they receive
Patients with early gastric cancerNot described
Receives: Other: Blood collection
Patients with advanced gastric cancerNot described
Receives: Other: Blood collection
healthy personNot described
Receives: Other: Blood collection
Patients with colorectal cancerNot described
Receives: Other: Blood collection
Liver cancer patientsNot described
Receives: Other: Blood collection
Breast cancer patientNot described
Receives: Other: Blood collection
Patients with atrophic gastritisNot described
Receives: Other: Blood collection

What is being measured

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

  1. Getting serum

    Obtain subject serum

    Measured: 2023-12-30

Timeline

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

  1. First posted18 Aug 2021
  2. Study start1 Jan 2021
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 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
Cohort
Time perspective
Prospective
Enrolment
530 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010863
Sponsor's protocol ID
SAHoWMU-CR2021-02-404
Acronym
GCMDKD
Status last verified
Aug 2021
First submitted
11 Aug 2021
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim Y, Byeon SJ, Hur J, Lee K, Kim D, Ahn JH, Lee SH, You WK, Kim ST, Park SH, Kang WK, Kim KM, Lee J. High delta-like ligand 4 expression correlates with a poor clinical outcome in gastric cancer. J Cancer. 2019 Jun 2;10(14):3172-3178. doi: 10.7150/jca.30257. eCollection 2019.

    PubMed 31289587

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.

    PubMed 30620402

  • Chen J, Xu M, Zhang Y, Gao C, Sun P. Effects of a stepwise, local patient-specific early oral feeding schedule after gastric cancer surgery: a single-center retrospective study from China. Sci Rep. 2019 Nov 12;9(1):16539. doi: 10.1038/s41598-019-52629-0.

    PubMed 31719569

  • Woll E, Thaler J, Keil F, Gruenberger B, Hejna M, Eisterer W, Fridrik MA, Ulmer H, Trommet V, Huemer F, Weiss L, Greil R. Oxaliplatin/Irinotecan/Bevacizumab Followed by Docetaxel/Bevacizumab in Inoperable Locally Advanced or Metastatic Gastric Cancer Patients - AGMT_GASTRIC-3. Anticancer Res. 2017 Oct;37(10):5553-5558. doi: 10.21873/anticanres.11987.

    PubMed 28982869

  • Petrovic M, Bukumiric Z, Zdravkovic V, Mitrovic S, Atkinson HD, Jurisic V. The prognostic significance of the circulating neuroendocrine markers chromogranin A, pro-gastrin-releasing peptide, and neuron-specific enolase in patients with small-cell lung cancer. Med Oncol. 2014 Feb;31(2):823. doi: 10.1007/s12032-013-0823-1. Epub 2013 Dec 30.

    PubMed 24375395

  • Tsai MM, Wang CS, Tsai CY, Huang HW, Chi HC, Lin YH, Lu PH, Lin KH. Potential Diagnostic, Prognostic and Therapeutic Targets of MicroRNAs in Human Gastric Cancer. Int J Mol Sci. 2016 Jun 16;17(6):945. doi: 10.3390/ijms17060945.

    PubMed 27322246

  • Necula L, Matei L, Dragu D, Neagu AI, Mambet C, Nedeianu S, Bleotu C, Diaconu CC, Chivu-Economescu M. Recent advances in gastric cancer early diagnosis. World J Gastroenterol. 2019 May 7;25(17):2029-2044. doi: 10.3748/wjg.v25.i17.2029.

    PubMed 31114131

  • Shibutani M, Maeda K, Nagahara H, Ohtani H, Sakurai K, Yamazoe A, Kimura K, Toyokawa T, Amano R, Kubo N, Tanaka H, Muguruma K, Ohira M, Hirakawa K. Significance of Markers of Systemic Inflammation for Predicting Survival and Chemotherapeutic Outcomes and Monitoring Tumor Progression in Patients with Unresectable Metastatic Colorectal Cancer. Anticancer Res. 2015 Sep;35(9):5037-46.

    PubMed 26254405

  • Ning S, Wei W, Li J, Hou B, Zhong J, Xie Y, Liu H, Mo X, Chen J, Zhang L. Clinical significance and diagnostic capacity of serum TK1, CEA, CA 19-9 and CA 72-4 levels in gastric and colorectal cancer patients. J Cancer. 2018 Jan 1;9(3):494-501. doi: 10.7150/jca.21562. eCollection 2018.

    PubMed 29483954

  • Zhao X, Bian F, Sun L, Cai L, Li L, Zhao Y. Microfluidic Generation of Nanomaterials for Biomedical Applications. Small. 2020 Mar;16(9):e1901943. doi: 10.1002/smll.201901943. Epub 2019 Jul 1.

    PubMed 31259464

  • Bigbee WL, Gopalakrishnan V, Weissfeld JL, Wilson DO, Dacic S, Lokshin AE, Siegfried JM. A multiplexed serum biomarker immunoassay panel discriminates clinical lung cancer patients from high-risk individuals found to be cancer-free by CT screening. J Thorac Oncol. 2012 Apr;7(4):698-708. doi: 10.1097/JTO.0b013e31824ab6b0.

    PubMed 22425918

  • Bando H, Yoshino T, Shinozaki E, Nishina T, Yamazaki K, Yamaguchi K, Yuki S, Kajiura S, Fujii S, Yamanaka T, Tsuchihara K, Ohtsu A. Simultaneous identification of 36 mutations in KRAS codons 61 and 146, BRAF, NRAS, and PIK3CA in a single reaction by multiplex assay kit. BMC Cancer. 2013 Sep 3;13:405. doi: 10.1186/1471-2407-13-405.

    PubMed 24006859

  • Hofmann JN, Yu K, Bagni RK, Lan Q, Rothman N, Purdue MP. Intra-individual variability over time in serum cytokine levels among participants in the prostate, lung, colorectal, and ovarian cancer screening Trial. Cytokine. 2011 Nov;56(2):145-8. doi: 10.1016/j.cyto.2011.06.012. Epub 2011 Jul 20.

    PubMed 21764327

  • Nitsch SM, Pries R, Wollenberg B. Head and neck cancer triggers increased IL-6 production of CD34+ stem cells from human cord blood. In Vivo. 2007 May-Jun;21(3):493-8.

    PubMed 17591359

  • Zhao Y, Zhao X, Pei X, Hu J, Zhao W, Chen B, Gu Z. Multiplex detection of tumor markers with photonic suspension array. Anal Chim Acta. 2009 Feb 2;633(1):103-8. doi: 10.1016/j.aca.2008.11.035. Epub 2008 Nov 25.

    PubMed 19110123

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer, run by Second Affiliated Hospital of Wenzhou Medical University 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 11 inclusion and 7 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 18 Aug 2021. 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 Weijian Sun, PhD (13857772361, fame198288@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Getting serum (time frame: 2023-12-30). 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 NCT05010863, which also lists 16 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 18 Aug 2021.

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GCMDKD Clinical Trial NCT05010863 | AzTrials