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

NCT05556603 | Recruiting DMC

• 1 other identifier: RSCD2022003
• Study Type: observational
• Target: 7,062
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of the cfDNA methylation-based model in detecting pancreatic cancer.

  30 months

• The performance of the cfDNA methylation-based model in pancreatic cancer early detection in participants at high risk for pancreatic cancer.

  90 months

Secondary Outcomes (3)

• The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages.

  30 months

• Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers.

  30 months

• Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting pancreatic cancer, respectively.

  30 months

Other Outcomes (1)

• Sensitivity and specificity of a blood miRNA-based model in detecting pancreatic cancer.

  30 months

Study Arms (4)

Cancer arm

Participants with new diagnosis of pancreatic cancer, from whom a blood sample will be collected.

Benign disease arm

Participants with benign pancreatic diseases, from whom a blood sample will be collected.

Healthy arm

Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected.

High risk for pancreatic cancer arm

Participants with high risk for pancreatic cancer, from whom a blood sample will be collected.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator

Study Sites (3)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

ACTIVE NOT RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

ACTIVE NOT RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Neoplasms

Study Officials

• Baiyong Shen, M.D.&Ph.D

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Qian Zhan, M.D.

CONTACT

+86-021-64370045 ext. 670903; zhanxi80@126.com

Yuzi Zhang, M.D.

CONTACT

+86-021-60293798; Z_Zhangyuzi@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 27, 2022
• Study Start: December 28, 2022
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)