CancerNCT05556603
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in PANCEATIC Cancer (ASCEND-PANCREATIC)
An observational study of Cancer, run by Ruijin Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 7,062 participants
- Where
- 3 sitesChina
- Study dates
- 28 Dec 2022to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Show all 30Show fewer
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Qian Zhan, MD, +86-021-64370045 ext. 670903, zhanxi80@126.com
- Active, not recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
- Active, not recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study
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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the cfDNA methylation-based model in detecting pancreatic cancer.
Measured: 30 months
The performance of the cfDNA methylation-based model in pancreatic cancer early detection in participants at high risk for pancreatic cancer.
Measured: 90 months
Secondary outcomes (3)
The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages.
Measured: 30 months
Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers.
Measured: 30 months
Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting pancreatic cancer, respectively.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start28 Dec 2022
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7,062 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Baiyong Shen, M.D.&Ph.D, Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556603
- Sponsor's protocol ID
- RSCD2022003
- Status last verified
- Feb 2023
- First submitted
- 25 Sep 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steel N, Ford JA, Newton JN, Davis ACJ, Vos T, Naghavi M, Glenn S, Hughes A, Dalton AM, Stockton D, Humphreys C, Dallat M, Schmidt J, Flowers J, Fox S, Abubakar I, Aldridge RW, Baker A, Brayne C, Brugha T, Capewell S, Car J, Cooper C, Ezzati M, Fitzpatrick J, Greaves F, Hay R, Hay S, Kee F, Larson HJ, Lyons RA, Majeed A, McKee M, Rawaf S, Rutter H, Saxena S, Sheikh A, Smeeth L, Viner RM, Vollset SE, Williams HC, Wolfe C, Woolf A, Murray CJL. Changes in health in the countries of the UK and 150 English Local Authority areas 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018 Nov 3;392(10158):1647-1661. doi: 10.1016/S0140-6736(18)32207-4. Epub 2018 Oct 24.
PubMed 30497795Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Smith RA, Andrews KS, Brooks D, Fedewa SA, Manassaram-Baptiste D, Saslow D, Brawley OW, Wender RC. Cancer screening in the United States, 2018: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2018 Jul;68(4):297-316. doi: 10.3322/caac.21446. Epub 2018 May 30.
PubMed 29846940Chen M, Zhao H. Next-generation sequencing in liquid biopsy: cancer screening and early detection. Hum Genomics. 2019 Aug 1;13(1):34. doi: 10.1186/s40246-019-0220-8.
PubMed 31370908Moore LD, Le T, Fan G. DNA methylation and its basic function. Neuropsychopharmacology. 2013 Jan;38(1):23-38. doi: 10.1038/npp.2012.112. Epub 2012 Jul 11.
PubMed 22781841Curradi M, Izzo A, Badaracco G, Landsberger N. Molecular mechanisms of gene silencing mediated by DNA methylation. Mol Cell Biol. 2002 May;22(9):3157-73. doi: 10.1128/MCB.22.9.3157-3173.2002.
PubMed 11940673Guibert S, Weber M. Functions of DNA methylation and hydroxymethylation in mammalian development. Curr Top Dev Biol. 2013;104:47-83. doi: 10.1016/B978-0-12-416027-9.00002-4.
PubMed 23587238Widschwendter M, Jones A, Evans I, Reisel D, Dillner J, Sundstrom K, Steyerberg EW, Vergouwe Y, Wegwarth O, Rebitschek FG, Siebert U, Sroczynski G, de Beaufort ID, Bolt I, Cibula D, Zikan M, Bjorge L, Colombo N, Harbeck N, Dudbridge F, Tasse AM, Knoppers BM, Joly Y, Teschendorff AE, Pashayan N; FORECEE (4C) Consortium. Epigenome-based cancer risk prediction: rationale, opportunities and challenges. Nat Rev Clin Oncol. 2018 May;15(5):292-309. doi: 10.1038/nrclinonc.2018.30. Epub 2018 Feb 27.
PubMed 29485132Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013 Mar 29;339(6127):1546-58. doi: 10.1126/science.1235122.
PubMed 23539594Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6.
PubMed 28263317Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.
PubMed 24901436Church TR, Wandell M, Lofton-Day C, Mongin SJ, Burger M, Payne SR, Castanos-Velez E, Blumenstein BA, Rosch T, Osborn N, Snover D, Day RW, Ransohoff DF; PRESEPT Clinical Study Steering Committee, Investigators and Study Team. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut. 2014 Feb;63(2):317-25. doi: 10.1136/gutjnl-2012-304149. Epub 2013 Feb 13.
PubMed 23408352Ilse P, Biesterfeld S, Pomjanski N, Wrobel C, Schramm M. Analysis of SHOX2 methylation as an aid to cytology in lung cancer diagnosis. Cancer Genomics Proteomics. 2014 Sep-Oct;11(5):251-8.
PubMed 25331797中国肺癌防治联盟 中, 肺癌工作委员会. 肺癌筛查与管理中国专家共识. . 国际呼吸杂志 2019;39(21):1604-1615.
Cristiano S, Leal A, Phallen J, Fiksel J, Adleff V, Bruhm DC, Jensen SO, Medina JE, Hruban C, White JR, Palsgrove DN, Niknafs N, Anagnostou V, Forde P, Naidoo J, Marrone K, Brahmer J, Woodward BD, Husain H, van Rooijen KL, Orntoft MW, Madsen AH, van de Velde CJH, Verheij M, Cats A, Punt CJA, Vink GR, van Grieken NCT, Koopman M, Fijneman RJA, Johansen JS, Nielsen HJ, Meijer GA, Andersen CL, Scharpf RB, Velculescu VE. Genome-wide cell-free DNA fragmentation in patients with cancer. Nature. 2019 Jun;570(7761):385-389. doi: 10.1038/s41586-019-1272-6. Epub 2019 May 29.
PubMed 31142840
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study
- ClinicalTrials.gov ID
- NCT05556603
- Acronym / sponsor ID
- RSCD2022003
- Conditions
- Cancer
- Keywords
- Cancer, liquid biopsy, cell-free DNA (cfDNA) methylation, circulating tumor DNA (ctDNA) mutation, whole blood miRNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,062 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of the cfDNA methylation-based model in detecting pancreatic cancer.
Time frame: 30 months
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
3 secondary outcomes
The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages.
Time frame: 30 months
Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers.
Time frame: 30 months
Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting pancreatic cancer, respectively.
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 30497795Steel N, Ford JA, Newton JN, Davis ACJ, Vos T, Naghavi M, Glenn S, Hughes A, Dalton AM, Stockton D, Humphreys C, Dallat M, Schmidt J, Flowers J, Fox S, Abubakar I, Aldridge RW, Baker A, Brayne C, Brugha T, Capewell S, Car J, Cooper C, Ezzati M, Fitzpatrick J, Greaves F, Hay R, Hay S, Kee F, Larson HJ, Lyons RA, Majeed A, McKee M, Rawaf S, Rutter H, Saxena S, Sheikh A, Smeeth L, Viner RM, Vollset SE, Williams HC, Wolfe C, Woolf A, Murray CJL. Changes in health in the countries of the UK and 150 English Local Authority areas 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018 Nov 3;392(10158):1647-1661. doi: 10.1016/S0140-6736(18)32207-4. Epub 2018 Oct 24.
- Background: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Background: PubMed 29846940Smith RA, Andrews KS, Brooks D, Fedewa SA, Manassaram-Baptiste D, Saslow D, Brawley OW, Wender RC. Cancer screening in the United States, 2018: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2018 Jul;68(4):297-316. doi: 10.3322/caac.21446. Epub 2018 May 30.
- Background: PubMed 31370908Chen M, Zhao H. Next-generation sequencing in liquid biopsy: cancer screening and early detection. Hum Genomics. 2019 Aug 1;13(1):34. doi: 10.1186/s40246-019-0220-8.
- Background: PubMed 22781841Moore LD, Le T, Fan G. DNA methylation and its basic function. Neuropsychopharmacology. 2013 Jan;38(1):23-38. doi: 10.1038/npp.2012.112. Epub 2012 Jul 11.
- Background: PubMed 11940673Curradi M, Izzo A, Badaracco G, Landsberger N. Molecular mechanisms of gene silencing mediated by DNA methylation. Mol Cell Biol. 2002 May;22(9):3157-73. doi: 10.1128/MCB.22.9.3157-3173.2002.
- Background: PubMed 23587238Guibert S, Weber M. Functions of DNA methylation and hydroxymethylation in mammalian development. Curr Top Dev Biol. 2013;104:47-83. doi: 10.1016/B978-0-12-416027-9.00002-4.
- Background: PubMed 29485132Widschwendter M, Jones A, Evans I, Reisel D, Dillner J, Sundstrom K, Steyerberg EW, Vergouwe Y, Wegwarth O, Rebitschek FG, Siebert U, Sroczynski G, de Beaufort ID, Bolt I, Cibula D, Zikan M, Bjorge L, Colombo N, Harbeck N, Dudbridge F, Tasse AM, Knoppers BM, Joly Y, Teschendorff AE, Pashayan N; FORECEE (4C) Consortium. Epigenome-based cancer risk prediction: rationale, opportunities and challenges. Nat Rev Clin Oncol. 2018 May;15(5):292-309. doi: 10.1038/nrclinonc.2018.30. Epub 2018 Feb 27.
- Background: PubMed 23539594Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013 Mar 29;339(6127):1546-58. doi: 10.1126/science.1235122.
- Background: PubMed 28263317Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6.
- Background: PubMed 24901436Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.
- Background: PubMed 23408352Church TR, Wandell M, Lofton-Day C, Mongin SJ, Burger M, Payne SR, Castanos-Velez E, Blumenstein BA, Rosch T, Osborn N, Snover D, Day RW, Ransohoff DF; PRESEPT Clinical Study Steering Committee, Investigators and Study Team. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut. 2014 Feb;63(2):317-25. doi: 10.1136/gutjnl-2012-304149. Epub 2013 Feb 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Baiyong Shen, M.D.&Ph.D study director
Ruijin Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Ruijin Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Zhan, M.D. (+86-021-64370045 ext. 670903, zhanxi80@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the cfDNA methylation-based model in detecting pancreatic cancer. (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05556603, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.