Gastric CancerNCT02848066
Glycans Bound to Serum Haptoglobin: a Novel Gastric Cancer Tumor Biomarker
An observational study of Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate sensitivity and specificity of newly defined tumor biomarker with gastric cancer pts and cancer-free healthy volunteers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Blood sample(10cc) collection
- Type of treatment
- Surgery or procedure
- How many people
- 353 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Sep 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Arm1- Gastric cancer patient: 150 subjects Arm2- Cancer-free healthy volunteers : 203
Arm1 (Gastric cancer patient)
- Inclusion Criteria:
- Male or female over 19 years
- Patients with histologically Gastric Cancer (included Gastroesphageal junction)
- Primary gastric cancer or/and metastatic gastric cancer.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
- Exclusion Criteria:
- Prior or present history of malignancies other than gastric cancer
- Any condition that confounds the ability to interpret data from the study under the investigational confirmed.
Arm2 (Cancer-free healthy volunteers)
- Inclusion Criteria:
- Male or female over 19 years
- Cancer-free status.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
- Exclusion Criteria:
- Prior or present history of malignancies (included gastric cancer)
- Any condition that confounds the ability to interpret data from the study under the investigational confirmed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Parallel, Single-Site Study to Evaluate Sensitivity and Specificity of Newly Defined Diagnosed-biomarker for Gastric Cancer Pts and Cancer-free Healthy Volunteers
The purpose of this study is to evaluate sensitivity and specificity of newly defined tumor biomarker with gastric cancer pts and cancer-free healthy volunteers.
Read the detailed description
Measurements of specific glycosylation changes in serum haptoglobin.
- Conditions
- Gastric Cancer
- Being tested
- Blood sample(10cc) collection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample(10cc) collectionProcedure or surgery
In both groups, serum haptoglobins to be collected and analyzed
| Study group | Role | What they receive |
|---|---|---|
| Gastric Cancer patients | This arm is composed of the gastric cancer patients. It is perfomed a blood sampling to them after the research registration. Receives: Procedure: Blood sample(10cc) collection | |
| Cancer-free healthy volunteers | This arm is composed of the cancer-free healthy volunteers. It is perfomed a blood sampling to them after the research registration. Receives: Procedure: Blood sample(10cc) collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(Area Under the Curve)
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Relative abundance of glycosylations
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848066
- Sponsor's protocol ID
- 2015-07-146
- Status last verified
- May 2019
- First submitted
- 21 Jul 2016
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Etzioni R, Urban N, Ramsey S, McIntosh M, Schwartz S, Reid B, Radich J, Anderson G, Hartwell L. The case for early detection. Nat Rev Cancer. 2003 Apr;3(4):243-52. doi: 10.1038/nrc1041.
PubMed 12671663Paik YK, Kim H, Lee EY, Kwon MS, Cho SY. Overview and introduction to clinical proteomics. Methods Mol Biol. 2008;428:1-31. doi: 10.1007/978-1-59745-117-8_1.
PubMed 18287765Asazawa H, Kamada Y, Takeda Y, Takamatsu S, Shinzaki S, Kim Y, Nezu R, Kuzushita N, Mita E, Kato M, Miyoshi E. Serum fucosylated haptoglobin in chronic liver diseases as a potential biomarker of hepatocellular carcinoma development. Clin Chem Lab Med. 2015 Jan;53(1):95-102. doi: 10.1515/cclm-2014-0427.
PubMed 25060348Hoagland LF 4th, Campa MJ, Gottlin EB, Herndon JE 2nd, Patz EF Jr. Haptoglobin and posttranslational glycan-modified derivatives as serum biomarkers for the diagnosis of nonsmall cell lung cancer. Cancer. 2007 Nov 15;110(10):2260-8. doi: 10.1002/cncr.23049.
PubMed 17918261Thompson S, Cantwell BM, Matta KL, Turner GA. Parallel changes in the blood levels of abnormally-fucosylated haptoglobin and alpha 1,3 fucosyltransferase in relationship to tumour burden: more evidence for a disturbance of fucose metabolism in cancer. Cancer Lett. 1992 Aug 14;65(2):115-21. doi: 10.1016/0304-3835(92)90154-n.
PubMed 1511415Park SY, Lee SH, Kawasaki N, Itoh S, Kang K, Hee Ryu S, Hashii N, Kim JM, Kim JY, Hoe Kim J. alpha1-3/4 fucosylation at Asn 241 of beta-haptoglobin is a novel marker for colon cancer: a combinatorial approach for development of glycan biomarkers. Int J Cancer. 2012 May 15;130(10):2366-76. doi: 10.1002/ijc.26288. Epub 2011 Sep 22.
PubMed 21780104Dennis JW, Granovsky M, Warren CE. Glycoprotein glycosylation and cancer progression. Biochim Biophys Acta. 1999 Dec 6;1473(1):21-34. doi: 10.1016/s0304-4165(99)00167-1.
PubMed 10580127
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Parallel, Single-Site Study to Evaluate Sensitivity and Specificity of Newly Defined Diagnosed-biomarker for Gastric Cancer Pts and Cancer-free Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02848066
- Acronym / sponsor ID
- 2015-07-146
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Jul 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.
The purpose of this study is to evaluate sensitivity and specificity of newly defined tumor biomarker with gastric cancer pts and cancer-free healthy volunteers.
Detailed description
Measurements of specific glycosylation changes in serum haptoglobin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Cancer patients | – | Procedure: Blood sample(10cc) collectionThis arm is composed of the gastric cancer patients. It is perfomed a blood sampling to them after the research registration. |
| Cancer-free healthy volunteers | – | Procedure: Blood sample(10cc) collectionThis arm is composed of the cancer-free healthy volunteers. It is perfomed a blood sampling to them after the research registration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Arm1- Gastric cancer patient: 150 subjects Arm2- Cancer-free healthy volunteers : 203
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 sample(10cc) collectionIn both groups, serum haptoglobins to be collected and analyzed | Procedure or surgery | Cancer-free healthy volunteers, Gastric Cancer patients |
Primary outcome
AUC(Area Under the Curve)
Time frame: through study completion, an average of 1 year
1 secondary outcome
Relative abundance of glycosylations
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Background: PubMed 12671663Etzioni R, Urban N, Ramsey S, McIntosh M, Schwartz S, Reid B, Radich J, Anderson G, Hartwell L. The case for early detection. Nat Rev Cancer. 2003 Apr;3(4):243-52. doi: 10.1038/nrc1041.
- Background: PubMed 18287765Paik YK, Kim H, Lee EY, Kwon MS, Cho SY. Overview and introduction to clinical proteomics. Methods Mol Biol. 2008;428:1-31. doi: 10.1007/978-1-59745-117-8_1.
- Background: PubMed 25060348Asazawa H, Kamada Y, Takeda Y, Takamatsu S, Shinzaki S, Kim Y, Nezu R, Kuzushita N, Mita E, Kato M, Miyoshi E. Serum fucosylated haptoglobin in chronic liver diseases as a potential biomarker of hepatocellular carcinoma development. Clin Chem Lab Med. 2015 Jan;53(1):95-102. doi: 10.1515/cclm-2014-0427.
- Background: PubMed 17918261Hoagland LF 4th, Campa MJ, Gottlin EB, Herndon JE 2nd, Patz EF Jr. Haptoglobin and posttranslational glycan-modified derivatives as serum biomarkers for the diagnosis of nonsmall cell lung cancer. Cancer. 2007 Nov 15;110(10):2260-8. doi: 10.1002/cncr.23049.
- Background: PubMed 1511415Thompson S, Cantwell BM, Matta KL, Turner GA. Parallel changes in the blood levels of abnormally-fucosylated haptoglobin and alpha 1,3 fucosyltransferase in relationship to tumour burden: more evidence for a disturbance of fucose metabolism in cancer. Cancer Lett. 1992 Aug 14;65(2):115-21. doi: 10.1016/0304-3835(92)90154-n.
- Background: PubMed 21780104Park SY, Lee SH, Kawasaki N, Itoh S, Kang K, Hee Ryu S, Hashii N, Kim JM, Kim JY, Hoe Kim J. alpha1-3/4 fucosylation at Asn 241 of beta-haptoglobin is a novel marker for colon cancer: a combinatorial approach for development of glycan biomarkers. Int J Cancer. 2012 May 15;130(10):2366-76. doi: 10.1002/ijc.26288. Epub 2011 Sep 22.
- Background: PubMed 10580127Dennis JW, Granovsky M, Warren CE. Glycoprotein glycosylation and cancer progression. Biochim Biophys Acta. 1999 Dec 6;1473(1):21-34. doi: 10.1016/s0304-4165(99)00167-1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(Area Under the Curve) (time frame: through study completion, an average of 1 year). 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 NCT02848066, which also lists 7 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 20 May 2019.