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

Last updated: February 10, 2022
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT05224596
B2020-390R
  • Ages 40-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 498
Study Start date:
January 18, 2021
Estimated Completion Date:
September 22, 2022

Connect with a study center

  • ZhongShan hospital FuDan university

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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