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AssesSment of Early-deteCtion basEd oN liquiD Biopsy in GASTRIC Cancer, ASCEND-Gastric (ASCEND-Gastric)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05224596
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : February 28, 2022
Sponsor:
Collaborator:
Guangzhou Burning Rock Bioengineering Ltd.
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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Brief Summary:
ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.

Condition or disease Intervention/treatment
Cancer Diagnostic Test: Blood draw and blood-based biomarkers analyses

Study Design
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Study Type : Observational
Estimated Enrollment : 498 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gastric Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : September 22, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cancer arm
Baseline blood samples will be collected from new diagnosis cancer participants.
 Diagnostic Test: Blood draw and blood-based biomarkers analyses
blood-based biomarkers analyses
Benign disease arm
Baseline blood samples will be collected from new diagnosis benign gastric disease participants.
 Diagnostic Test: Blood draw and blood-based biomarkers analyses
blood-based biomarkers analyses


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and specificity of the cfDNA methylation-based model in detecting gastric cancer. [ Time Frame: 30 months ]

Secondary Outcome Measures :
  1. The differences of sensitivity and specificity in gastric cancer participants at different clinical stages. [ Time Frame: 30 months ]
  2. Sensitivity and specificity for detecting gastric cancer of a cfDNA methylation-based model, in combination with other biomarkers. [ Time Frame: 30 months ]
  3. Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting gastric cancer, respectively. [ Time Frame: 30 months ]

Other Outcome Measures:
  1. Sensitivity and specificity of a blood miRNA-based model in detecting gastric cancer. [ Time Frame: 30 months ]

Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligible participants in cancer arm will be recruited with new diagnosis of gastric cancer and without any types of tumor treatment.

Eligible participants in benign disease arm will be recruited with new diagnosis of benign gastric disease and without any types of treatment.

Criteria

Inclusion Criteria for Cancer Arm Participants:

  • Age 40-75 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:

A. Pathologically confirmed cancer diagnosis within 42 days prior to blood draw.

B. 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.

Exclusion Criteria for Cancer Arm Participants:

  • 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.

Inclusion Criteria for Benign Disease Arm Participants:

  • Age 40-75 years at the day of consenting to the study.
  • Able to provide a written informed consent.
  • Able to provide sufficient and qualified blood samples for study tests.
  • Have either of the following:

A. Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection.

B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw.

Exclusion Criteria for Benign Disease Arm Participants:

  • Insufficient qualified blood sample for study test.
  • 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 study blood draw.
  • Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05224596


Contacts
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Contact: Yihong Sun, MD +86-021-65642662 sun.yihong@zs-hospital.sh.cn
Contact: Xuefei Wang, MD +86-021-65642662 wang.xuefei@zs-hospital.sh.cn

Locations
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China, Shanghai
ZhongShan hospital FuDan university Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yihong Sun, MD    86-13701735406    sun.yihong@zs-hospital.sh.cn   
Principal Investigator: Yihong Sun, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Guangzhou Burning Rock Bioengineering Ltd.
Investigators
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Principal Investigator: Yihong Sun Sun, MD Zhongshan Hospital, Fudan University,China
Principal Investigator: Xuefei Wang, MD Zhongshan Hospital, Fudan University,China
More Information
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Publications:
Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Marie Quinn A, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG; TRACERx consortium; PEACE consortium; Swanton C. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017 Apr 26;545(7655):446-451. doi: 10.1038/nature22364. Erratum In: Nature. 2017 Dec 20;:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT05224596    
Other Study ID Numbers: B2020-390R
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
Cancer
liquid biopsy
cell-free DNA (cfDNA) methylation
circulating tumor DNA (ctDNA) mutation
whole blood miRNA
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases