NCT05556603Recruiting
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in PANCEATIC Cancer (ASCEND-PANCREATIC)
Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study
Source: ClinicalTrials.gov · Last updated 6 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 7062 (estimated)
- First submitted
- 25 Sept 2022
- Start date
- 28 Dec 2022
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Ruijin Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT05556603
What you commit to
- Study type: Observational
- Planned participants: 7062
- From 28 Dec 2022 to the primary completion date, 30 Jun 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- 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.
- 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.
Other illness
- With other known malignant tumors or multiple primary tumors.
- With autoimmune or other diseases with severe comorbidities.
Other
- Insufficient qualified blood samples.
- During pregnancy or lactation.
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
Who the study is looking for
- Age 40-75 years old.
- Able to provide a written informed consent.
- No prior cancer treatment (local or systematic) with either of the following:
- Pathologically confirmed cancer diagnosis within 42 days prior to blood draw.
- 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.
- 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:
- Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection.
- 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.
- 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.
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.