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

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

NCT ID: NCT05556603

Condition: Cancer

Conditions: Keywords:
Cancer
liquid biopsy
cell-free DNA (cfDNA) methylation
circulating tumor DNA (ctDNA) mutation
whole blood miRNA

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
Eligible participants will be recruited from medical centers and assigned into three arms to develop a predictive diagnostic model in pancreatic cancer, including participants with new diagnosis of malignancy or corresponding benign disease and participants without the presence of malignancy or benign diseases. Participants with high risk for pancreatic cancer will be recruited from medical centers to evaluate the performance of pancreatic cancer early detection test.

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 40 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address:
City: Shanghai
Zip: 200025
Country: China

Status: Recruiting

Contact:
Last name: Qian Zhan, MD

Phone: +86-021-64370045 ext. 670903
Email: zhanxi80@126.com

Facility:
Name: Huashan Hospital, Fudan University

Address:
City: Shanghai
Country: China

Status: Active, not recruiting

Facility:
Name: Zhongshan Hospital, Fudan University

Address:
City: Shanghai
Country: China

Status: Active, not recruiting

Start date: December 28, 2022

Completion date: December 31, 2029

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Collaborator:
Agency: Guangzhou Burning Rock Dx Co., Ltd.
Agency class: Industry

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05556603