AssesSment of Early-deteCtion basEd oN liquiD Biopsy in PANCEATIC Cancer (ASCEND-PANCREATIC)

Last updated: May 4, 2023
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

N/A

Clinical Study ID

NCT05556603
RSCD2022003
  • Ages 40-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

ASCEND-PANCREATIC is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, circulating tumor DNA (ctDNA) mutation, serum protein markers and blood miRNA markers, in which of 7,062 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers or benign diseases, along with healthy individuals. The performance of the pancreatic cancer detection test will be evaluated in participants with high risk of pancreatic cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria for Cancer Arm Participants:

  • Age 40-75 years old.

  • 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 old.

  • 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.

Inclusion Criteria for Healthy 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.

  • No cancer related symptoms within 30 days prior to study screening.

  • No abnormal medical examination within 30 days prior to screening.

  • Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

Exclusion Criteria for Healthy 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.

  • Have received or are undergoing curative cancer treatment within three years prior to study screening.

  • With autoimmune or other diseases with severe comorbidities.

Inclusion Criteria for High Risk for Pancreatic Cancer Arm Participants:

  • Age 40-75 years old.

  • Able to provide a written informed consent.

  • Able to provide sufficient and qualified blood samples for study tests.

  • Accompanied by known risk factors of pancreatic cancer, including carrier of any pathogenic variant, chronic pancreatitis and other risk factors.

Exclusion Criteria for High Risk for Pancreatic Cancer 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.

  • Received radical therapy within 3 years and without recurrence, with malignant tumors with pathogenic or suspected pathogenic variants of germ-line genetic susceptibility genes.

Study Design

Total Participants: 7062
Study Start date:
December 28, 2022
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

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