CancerASCEND-GastricNCT05224596
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in GASTRIC Cancer, ASCEND-Gastric
An observational study of Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Blood draw and blood-based biomarkers analyses
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2021to 22 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants in cancer arm will be recruited with new diagnosis of gastric cancer and without any types of tumor treatment. Eligible participants in benign disease arm will be recruited with new diagnosis of benign gastric disease and without any types of treatment.
Who may be able to join
- Age 40-75 years at the day of consenting to the study.
- 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 at the day of consenting to the study.
Show all 11Show 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.
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 11Show 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ZhongShan hospital FuDan university
Shanghai, Shanghai Municipality, 200032
Yihong Sun, MD, 86-13701735406, sun.yihong@zs-hospital.sh.cn
Yihong Sun, MD
About this study
Official title: Gastric Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study
ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.
- Conditions
- Cancer
- Being tested
- Blood draw and blood-based biomarkers analyses
- 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.
Blood draw and blood-based biomarkers analysesDiagnostic test
blood-based biomarkers analyses
| Study group | Role | What they receive |
|---|---|---|
| Cancer arm | Baseline blood samples will be collected from new diagnosis cancer participants. Receives: Diagnostic Test: Blood draw and blood-based biomarkers analyses | |
| Benign disease arm | Baseline blood samples will be collected from new diagnosis benign gastric disease participants. Receives: Diagnostic Test: Blood draw and blood-based biomarkers analyses |
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 gastric cancer.
Measured: 30 months
Secondary outcomes (3)
The differences of sensitivity and specificity in gastric cancer participants at different clinical stages.
Measured: 30 months
Sensitivity and specificity for detecting gastric 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 gastric 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 posted4 Feb 2022
- Study start18 Jan 2021
- Primary completion30 May 2022 (estimated)
- Study completion22 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Bioengineering Ltd.
- Responsible party
- Sponsor
- Investigators
- Yihong Sun Sun, MD, Principal investigator, Zhongshan Hospital, Fudan University,ChinaXuefei Wang, MD, Principal investigator, Zhongshan Hospital, Fudan University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224596
- Sponsor's protocol ID
- B2020-390R
- Acronym
- ASCEND-Gastric
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Sano T, Coit DG, Kim HH, Roviello F, Kassab P, Wittekind C, Yamamoto Y, Ohashi Y. Proposal of a new stage grouping of gastric cancer for TNM classification: International Gastric Cancer Association staging project. Gastric Cancer. 2017 Mar;20(2):217-225. doi: 10.1007/s10120-016-0601-9. Epub 2016 Feb 20.
PubMed 26897166So JBY, Kapoor R, Zhu F, Koh C, Zhou L, Zou R, Tang YC, Goo PCK, Rha SY, Chung HC, Yoong J, Yap CT, Rao J, Chia CK, Tsao S, Shabbir A, Lee J, Lam KP, Hartman M, Yong WP, Too HP, Yeoh KG. Development and validation of a serum microRNA biomarker panel for detecting gastric cancer in a high-risk population. Gut. 2021 May;70(5):829-837. doi: 10.1136/gutjnl-2020-322065. Epub 2020 Oct 7.
PubMed 33028667Miki K. Gastric cancer screening using the serum pepsinogen test method. Gastric Cancer. 2006;9(4):245-53. doi: 10.1007/s10120-006-0397-0. Epub 2006 Nov 24.
PubMed 17235625Li MY, Zhang DQ, Lu X, Chen WC. [Comparison of two serological methods in screening gastric cancer and its precancerous condition]. Zhonghua Nei Ke Za Zhi. 2018 Dec 1;57(12):907-911. doi: 10.3760/cma.j.issn.0578-1426.2018.12.006. Chinese.
PubMed 30486559Hamashima C; Systematic Review Group and Guideline Development Group for Gastric Cancer Screening Guidelines. Update version of the Japanese Guidelines for Gastric Cancer Screening. Jpn J Clin Oncol. 2018 Jul 1;48(7):673-683. doi: 10.1093/jjco/hyy077.
PubMed 29889263Choi KS, Jun JK, Park EC, Park S, Jung KW, Han MA, Choi IJ, Lee HY. Performance of different gastric cancer screening methods in Korea: a population-based study. PLoS One. 2012;7(11):e50041. doi: 10.1371/journal.pone.0050041. Epub 2012 Nov 29.
PubMed 23209638Zhang X, Li M, Chen S, Hu J, Guo Q, Liu R, Zheng H, Jin Z, Yuan Y, Xi Y, Hua B. Endoscopic Screening in Asian Countries Is Associated With Reduced Gastric Cancer Mortality: A Meta-analysis and Systematic Review. Gastroenterology. 2018 Aug;155(2):347-354.e9. doi: 10.1053/j.gastro.2018.04.026. Epub 2018 Apr 30.
PubMed 29723507Chen 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 31370908Kang HM, Kim GH, Jeon HK, Kim DH, Jeon TY, Park DY, Jeong H, Chun WJ, Kim MH, Park J, Lim M, Kim TH, Cho YK. Circulating tumor cells detected by lab-on-a-disc: Role in early diagnosis of gastric cancer. PLoS One. 2017 Jun 29;12(6):e0180251. doi: 10.1371/journal.pone.0180251. eCollection 2017.
PubMed 28662130Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014 Jun;4(6):650-61. doi: 10.1158/2159-8290.CD-13-1014. Epub 2014 May 6.
PubMed 24801577Cristiano 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 31142840Cabel L, Decraene C, Bieche I, Pierga JY, Bennamoun M, Fuks D, Ferraz JM, Lefevre M, Baulande S, Bernard V, Vacher S, Mariani P, Proudhon C, Bidard FC, Louvet C. Limited Sensitivity of Circulating Tumor DNA Detection by Droplet Digital PCR in Non-Metastatic Operable Gastric Cancer Patients. Cancers (Basel). 2019 Mar 21;11(3):396. doi: 10.3390/cancers11030396.
PubMed 30901876Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13.
PubMed 23484797Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Marie Quinn A, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG; TRACERx consortium; PEACE consortium; Swanton C. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017 Apr 26;545(7655):446-451. doi: 10.1038/nature22364.
PubMed 28445469
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study
- ClinicalTrials.gov ID
- NCT05224596
- Acronym / sponsor ID
- ASCEND-Gastric / B2020-390R
- Conditions
- Cancer
- Keywords
- Cancer, liquid biopsy, cell-free DNA (cfDNA) methylation, circulating tumor DNA (ctDNA) mutation, whole blood miRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Bioengineering Ltd.
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 22 Sep 2022 (estimated)
- First posted
- 4 Feb 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-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer arm | – | Diagnostic Test: Blood draw and blood-based biomarkers analysesBaseline blood samples will be collected from new diagnosis cancer participants. |
| Benign disease arm | – | Diagnostic Test: Blood draw and blood-based biomarkers analysesBaseline blood samples will be collected from new diagnosis benign gastric disease participants. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants in cancer arm will be recruited with new diagnosis of gastric cancer and without any types of tumor treatment. Eligible participants in benign disease arm will be recruited with new diagnosis of benign gastric disease and without any types of treatment.
Key inclusion criteria (11 listed)
- Age 40-75 years at the day of consenting to the study.
- 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 (11 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw and blood-based biomarkers analysesblood-based biomarkers analyses | Diagnostic test | Benign disease arm, Cancer arm |
Primary outcome
Sensitivity and specificity of the cfDNA methylation-based model in detecting gastric cancer.
Time frame: 30 months
3 secondary outcomes
The differences of sensitivity and specificity in gastric cancer participants at different clinical stages.
Time frame: 30 months
Sensitivity and specificity for detecting gastric 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 gastric cancer, respectively.
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 26897166Sano T, Coit DG, Kim HH, Roviello F, Kassab P, Wittekind C, Yamamoto Y, Ohashi Y. Proposal of a new stage grouping of gastric cancer for TNM classification: International Gastric Cancer Association staging project. Gastric Cancer. 2017 Mar;20(2):217-225. doi: 10.1007/s10120-016-0601-9. Epub 2016 Feb 20.
- Background: PubMed 33028667So JBY, Kapoor R, Zhu F, Koh C, Zhou L, Zou R, Tang YC, Goo PCK, Rha SY, Chung HC, Yoong J, Yap CT, Rao J, Chia CK, Tsao S, Shabbir A, Lee J, Lam KP, Hartman M, Yong WP, Too HP, Yeoh KG. Development and validation of a serum microRNA biomarker panel for detecting gastric cancer in a high-risk population. Gut. 2021 May;70(5):829-837. doi: 10.1136/gutjnl-2020-322065. Epub 2020 Oct 7.
- Background: PubMed 17235625Miki K. Gastric cancer screening using the serum pepsinogen test method. Gastric Cancer. 2006;9(4):245-53. doi: 10.1007/s10120-006-0397-0. Epub 2006 Nov 24.
- Background: PubMed 30486559Li MY, Zhang DQ, Lu X, Chen WC. [Comparison of two serological methods in screening gastric cancer and its precancerous condition]. Zhonghua Nei Ke Za Zhi. 2018 Dec 1;57(12):907-911. doi: 10.3760/cma.j.issn.0578-1426.2018.12.006. Chinese.
- Background: PubMed 29889263Hamashima C; Systematic Review Group and Guideline Development Group for Gastric Cancer Screening Guidelines. Update version of the Japanese Guidelines for Gastric Cancer Screening. Jpn J Clin Oncol. 2018 Jul 1;48(7):673-683. doi: 10.1093/jjco/hyy077.
- Background: PubMed 23209638Choi KS, Jun JK, Park EC, Park S, Jung KW, Han MA, Choi IJ, Lee HY. Performance of different gastric cancer screening methods in Korea: a population-based study. PLoS One. 2012;7(11):e50041. doi: 10.1371/journal.pone.0050041. Epub 2012 Nov 29.
- Background: PubMed 29723507Zhang X, Li M, Chen S, Hu J, Guo Q, Liu R, Zheng H, Jin Z, Yuan Y, Xi Y, Hua B. Endoscopic Screening in Asian Countries Is Associated With Reduced Gastric Cancer Mortality: A Meta-analysis and Systematic Review. Gastroenterology. 2018 Aug;155(2):347-354.e9. doi: 10.1053/j.gastro.2018.04.026. Epub 2018 Apr 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 28662130Kang HM, Kim GH, Jeon HK, Kim DH, Jeon TY, Park DY, Jeong H, Chun WJ, Kim MH, Park J, Lim M, Kim TH, Cho YK. Circulating tumor cells detected by lab-on-a-disc: Role in early diagnosis of gastric cancer. PLoS One. 2017 Jun 29;12(6):e0180251. doi: 10.1371/journal.pone.0180251. eCollection 2017.
- Background: PubMed 24801577Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014 Jun;4(6):650-61. doi: 10.1158/2159-8290.CD-13-1014. Epub 2014 May 6.
- Background: PubMed 31142840Cristiano 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.
- 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. This study is not recruiting at the moment.
Yihong Sun Sun, MD principal investigator
Zhongshan Hospital, Fudan University,China
Xuefei Wang, MD principal investigator
Zhongshan Hospital, Fudan University,China
1 site 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 Shanghai Zhongshan Hospital at 1 site 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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihong Sun, MD (+86-021-65642662, sun.yihong@zs-hospital.sh.cn), 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 gastric cancer. (time frame: 30 months). 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 NCT05224596, which also lists 30 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 28 Feb 2022.