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

Launched by RUIJIN HOSPITAL · Sep 25, 2022

Keywords

ClinConnect Summary

The ASCEND-PANCREATIC trial is a study focused on finding ways to detect pancreatic cancer early. It involves testing blood samples from 7,062 participants to look for specific markers that could indicate the presence of cancer. These markers include changes in DNA and certain proteins found in the blood. The study will include individuals who are healthy, those with benign (non-cancerous) conditions, and those who are at high risk for pancreatic cancer, helping researchers understand how well these tests work in different groups of people.

To be eligible for the trial, participants must be between 40 and 75 years old and able to provide consent. Those in the cancer group should have no prior cancer treatment and must have a recent diagnosis of cancer or be highly suspected of having it. Individuals with benign diseases must also have a confirmed diagnosis without prior treatment. Healthy participants should not have any cancer symptoms or recent abnormal medical findings. Throughout the study, participants will provide blood samples, and they will be monitored for any potential side effects or issues related to the tests. This research aims to improve early detection of pancreatic cancer, which is often diagnosed at a later stage when treatment options are limited.

Gender

ALL

Eligibility criteria

• 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.