Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05556603

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan Hospital, Fudan University, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 30 months

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

    Time frame: 90 months

Secondary outcomes

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

    Time frame: 30 months

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

    Time frame: 30 months

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

    Time frame: 30 months

Other outcomes

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

    Time frame: 30 months

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Zhan, M.D.

CONTACT

[email protected]

+86-021-64370045 ext. 670903

Yuzi Zhang, M.D.

CONTACT

[email protected]

+86-021-60293798

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Guangzhou Burning Rock Dx Co., Ltd.

Registry information

Official study title

Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Sep 27, 2022
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.