Stomach NeoplasmsNCT02887612
ctDNA for Prediction of Relapse in Gastric Cancer
An observational study of Stomach Neoplasms, run by Sun Yat-sen University at 1 site in China.
Trial summary
Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. Surgery is the conventional treatment option for early and intermediate-stage stage gastric cancer, but postoperative relapse is the major issue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- ctDNA test
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Jun 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective clinical study collaborated with Geneseeq Technology Inc.200 of patients are planned. Total duration of the study is expected to be 2 years. The fresh tumor tissues/biopsies of each patient will be collected during the surgical treatment. The peripheral blood samples of each patient will be collected at the following time points: 1) prior to the surgical treatment; 2) 1 week after the surgical treatment; 3)every three months until disease progression or the end of the study. The collected fresh tumor tissues/biopsies or formalin fixed paraffin embedded (FFPE) blocks/sections, and peripheral blood samples will be further subjected for NGS analysis and NGS-based ctDNA mutation profiling, respectively.
Who may be able to join
- Male or female ≥ 18 years of age at first visit.
- Patients must have histologically confirmed early or intermediate-stage gastric cancer.
- Patients need to have surgical treatment.
- Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS analysis.
- Patients must be able to follow the study visit schedule and willing to provide peripheral blood samples at the indicated time point.
- Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.
Who cannot join
- Patients who cannot provide peripheral blood samples prior to the surgical treatment will be excluded.
- Patients with severe infection will be excluded.
- Patients with other serious disease besides early or intermediate-stage gastric cancer will be excluded.
- Pregnant women will be excluded.
- Patients who are alcoholic or drug abusers will be excluded.
- Patients with a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data will be excluded.
Trial locations and contacts
1 site in 1 country.
Feng Wang, MD.,PhD. contact
Shuang-zhen Chen, BS. contact
China1 site, 1 recruiting
- Recruiting
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Feng Wang, M.D,Ph.D, 86-18620880867, wangfeng@sysucc.org.cn
Ruihua Xu, M.D,Ph.D
About this study
Official title: A Prospective Study of Blood Circulating Tumor DNA for the Prediction of Postoperative Relapse in Early and Intermediate-Stage Gastric Cancer
Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. Surgery is the conventional treatment option for early and intermediate-stage stage gastric cancer, but postoperative relapse is the major issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring. The present clinical trial aims to elucidate the correlation between the serum ctDNA status and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical treatment, and explore the possibility of clinical utility of serum ctDNA as a clinical index to predict postoperative relapse.
Read the detailed description
Gastric cancer is one of the common malignant tumors in China, withrelatively high incident rate and mortality among the population. 95% of the gastric cancer is adenocarcinoma. 70% of the patients at the early stage show no obvious symptom, and only small number of them has nausea, vomiting, or symptoms that are similar to the of peptic ulcer disease.
Surgery is the conventional treatment option for early and middle stage gastric cancer, but postoperative relapse is the major issue. Currently, the only proven effective chemotherapies for gastric cancer are the taxane and platinum-based combination therapies. Also due to its molecular heterogeneity, the prognosis of gastric caner is highly varied among the patients. Therefore,there are not many effective targeting therapies available for the treatment of gastric cancer; and currently, trastuzumab and apatinib are the only two targeting drugs that have been clinically approved by CFDA.
Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation (2, 3). Although the mechanisms of its release have not been fully addressed, most reports considered apoptosis and/or necrosis of tumor cells as its main sources, which makes it a genomic reservoir of different tumor clones (4). Also, as its half-life is up to hours, ctDNA is reflecting the most up-to-date status of tumor genome(5). Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring.
By monitoring the serum ctDNA mutational profile using Next Generation Sequencing (NGS), the present clinical trial aims to elucidate the correlation between the serum ctDNA status and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical treatment, and explore the possibility of clinical utility of serum ctDNA as a clinical index to predict postoperative relapse. Moreover, by comparing the molecular profiles of patients with different prognosis, we may also screen out the molecular markers related to the prognosis of gastric cancer.
- Conditions
- Stomach Neoplasms
- Being tested
- ctDNA test
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA testOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value
the proportions of patients with positive serum ctDNA (in any follow-up) that have postoperative relapse
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
prognostic molecular markers
to screen out the molecular markers related to the prognosis of gastric cancer by comparing the molecular profiles of patients with different prognosis
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
- Investigators
- Rui-hua Xu, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887612
- Sponsor's protocol ID
- ctDNA001
- Status last verified
- Feb 2019
- First submitted
- 14 May 2016
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jahr S, Hentze H, Englisch S, Hardt D, Fackelmayer FO, Hesch RD, Knippers R. DNA fragments in the blood plasma of cancer patients: quantitations and evidence for their origin from apoptotic and necrotic cells. Cancer Res. 2001 Feb 15;61(4):1659-65.
PubMed 11245480Jiang P, Chan CW, Chan KC, Cheng SH, Wong J, Wong VW, Wong GL, Chan SL, Mok TS, Chan HL, Lai PB, Chiu RW, Lo YM. Lengthening and shortening of plasma DNA in hepatocellular carcinoma patients. Proc Natl Acad Sci U S A. 2015 Mar 17;112(11):E1317-25. doi: 10.1073/pnas.1500076112. Epub 2015 Feb 2.
PubMed 25646427Stroun M, Lyautey J, Lederrey C, Olson-Sand A, Anker P. About the possible origin and mechanism of circulating DNA apoptosis and active DNA release. Clin Chim Acta. 2001 Nov;313(1-2):139-42. doi: 10.1016/s0009-8981(01)00665-9.
PubMed 11694251Yu SC, Lee SW, Jiang P, Leung TY, Chan KC, Chiu RW, Lo YM. High-resolution profiling of fetal DNA clearance from maternal plasma by massively parallel sequencing. Clin Chem. 2013 Aug;59(8):1228-37. doi: 10.1373/clinchem.2013.203679. Epub 2013 Apr 19.
PubMed 23603797Yuan SQ, Nie RC, Huang YS, Chen YB, Wang SY, Sun XW, Li YF, Liu ZK, Chen YX, Yao YC, Xu Y, Qiu HB, Liang Y, Wang W, Liu ZX, Zhao Q, Xu RH, Zhou ZW, Wang F. Residual circulating tumor DNA after adjuvant chemotherapy effectively predicts recurrence of stage II-III gastric cancer. Cancer Commun (Lond). 2023 Dec;43(12):1312-1325. doi: 10.1002/cac2.12494. Epub 2023 Oct 14.
PubMed 37837629
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Blood Circulating Tumor DNA for the Prediction of Postoperative Relapse in Early and Intermediate-Stage Gastric Cancer
- ClinicalTrials.gov ID
- NCT02887612
- Acronym / sponsor ID
- ctDNA001
- Conditions
- Stomach Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- 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.
Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. Surgery is the conventional treatment option for early and intermediate-stage stage gastric cancer, but postoperative relapse is the major issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring. The present clinical trial aims to elucidate the correlation between the serum ctDNA status and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical treatment, and explore the possibility of clinical utility of serum ctDNA as a clinical index to predict postoperative relapse.
Detailed description
Gastric cancer is one of the common malignant tumors in China, withrelatively high incident rate and mortality among the population. 95% of the gastric cancer is adenocarcinoma. 70% of the patients at the early stage show no obvious symptom, and only small number of them has nausea, vomiting, or symptoms that are similar to the of peptic ulcer disease.
Surgery is the conventional treatment option for early and middle stage gastric cancer, but postoperative relapse is the major issue. Currently, the only proven effective chemotherapies for gastric cancer are the taxane and platinum-based combination therapies. Also due to its molecular heterogeneity, the prognosis of gastric caner is highly varied among the patients. Therefore,there are not many effective targeting therapies available for the treatment of gastric cancer; and currently, trastuzumab and apatinib are the only two targeting drugs that have been clinically approved by CFDA.
Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation (2, 3). Although the mechanisms of its release have not been fully addressed, most reports considered apoptosis and/or necrosis of tumor cells as its main sources, which makes it a genomic reservoir of different tumor clones (4). Also, as its half-life is up to hours, ctDNA is reflecting the most up-to-date status of tumor genome(5). Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring.
By monitoring the serum ctDNA mutational profile using Next Generation Sequencing (NGS), the present clinical trial aims to elucidate the correlation between the serum ctDNA status and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical treatment, and explore the possibility of clinical utility of serum ctDNA as a clinical index to predict postoperative relapse. Moreover, by comparing the molecular profiles of patients with different prognosis, we may also screen out the molecular markers related to the prognosis of gastric cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective clinical study collaborated with Geneseeq Technology Inc.200 of patients are planned. Total duration of the study is expected to be 2 years. The fresh tumor tissues/biopsies of each patient will be collected during the surgical treatment. The peripheral blood samples of each patient will be collected at the following time points: 1) prior to the surgical treatment; 2) 1 week after the surgical treatment; 3)every three months until disease progression or the end of the study. The collected fresh tumor tissues/biopsies or formalin fixed paraffin embedded (FFPE) blocks/sections, and peripheral blood samples will be further subjected for NGS analysis and NGS-based ctDNA mutation profiling, respectively.
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years of age at first visit.
- Patients must have histologically confirmed early or intermediate-stage gastric cancer.
- Patients need to have surgical treatment.
- Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS analysis.
- Patients must be able to follow the study visit schedule and willing to provide peripheral blood samples at the indicated time point.
Key exclusion criteria (6 listed)
- Patients who cannot provide peripheral blood samples prior to the surgical treatment will be excluded.
- Patients with severe infection will be excluded.
- Patients with other serious disease besides early or intermediate-stage gastric cancer will be excluded.
- Pregnant women will be excluded.
- Patients who are alcoholic or drug abusers will be excluded.
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 |
|---|---|---|
| ctDNA test | Other | – |
Primary outcome
Positive Predictive Value
Time frame: through study completion, an average of 2 years
the proportions of patients with positive serum ctDNA (in any follow-up) that have postoperative relapse
1 secondary outcome
prognostic molecular markers
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 11245480Jahr S, Hentze H, Englisch S, Hardt D, Fackelmayer FO, Hesch RD, Knippers R. DNA fragments in the blood plasma of cancer patients: quantitations and evidence for their origin from apoptotic and necrotic cells. Cancer Res. 2001 Feb 15;61(4):1659-65.
- Background: PubMed 25646427Jiang P, Chan CW, Chan KC, Cheng SH, Wong J, Wong VW, Wong GL, Chan SL, Mok TS, Chan HL, Lai PB, Chiu RW, Lo YM. Lengthening and shortening of plasma DNA in hepatocellular carcinoma patients. Proc Natl Acad Sci U S A. 2015 Mar 17;112(11):E1317-25. doi: 10.1073/pnas.1500076112. Epub 2015 Feb 2.
- Background: PubMed 11694251Stroun M, Lyautey J, Lederrey C, Olson-Sand A, Anker P. About the possible origin and mechanism of circulating DNA apoptosis and active DNA release. Clin Chim Acta. 2001 Nov;313(1-2):139-42. doi: 10.1016/s0009-8981(01)00665-9.
- Background: PubMed 23603797Yu SC, Lee SW, Jiang P, Leung TY, Chan KC, Chiu RW, Lo YM. High-resolution profiling of fetal DNA clearance from maternal plasma by massively parallel sequencing. Clin Chem. 2013 Aug;59(8):1228-37. doi: 10.1373/clinchem.2013.203679. Epub 2013 Apr 19.
- Derived from this study: PubMed 37837629Yuan SQ, Nie RC, Huang YS, Chen YB, Wang SY, Sun XW, Li YF, Liu ZK, Chen YX, Yao YC, Xu Y, Qiu HB, Liang Y, Wang W, Liu ZX, Zhao Q, Xu RH, Zhou ZW, Wang F. Residual circulating tumor DNA after adjuvant chemotherapy effectively predicts recurrence of stage II-III gastric cancer. Cancer Commun (Lond). 2023 Dec;43(12):1312-1325. doi: 10.1002/cac2.12494. Epub 2023 Oct 14.
- Individual participant dataSharing planned: Undecided
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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.
Feng Wang, MD.,PhD. contact
Shuang-zhen Chen, BS. contact
Rui-hua Xu principal investigator
Sun Yat-sen University
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 Stomach Neoplasms, run by Sun Yat-sen University 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 6 inclusion and 6 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 26 Feb 2019. 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 Feng Wang, MD.,PhD. (86-2087343804), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (time frame: through study completion, an average of 2 years). 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 NCT02887612, which also lists 5 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 26 Feb 2019.