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CA19-9

Basics

Aliases:
This biomarker is also known as:
  • carbohydrate antigen 19-9,
  • cancer antigen 19-9,

Description…

CA19-9 is a monoclonal antibody that was first discovered in the serum of patients with colon cancer. Since that time CA19-9 has been used as a tumor marker for a variety of cancers.

Attributes

QA State: Accepted
Type: Protein
Short Name:
HGNC Name:

Organs

The following organs have data associated with this biomarker…

Breast

Attributes

Phase: One
QA State: Curated

Overview

No additional data available.

Performance Comment

Ninety biomarkers were measured using a series of multiplexed immunoassays and results analyzed by the EDRN data management center splitting the cases and controls into training and validation sets, excluding subjects with DCIS or atypical hyperplasia from the training phase. We found little evidence that any of these markers can discriminate women with invasive cancer from those with benign breast conditions.

Supporting Study Data

The following studies/protocols provide evidence supporting CA19-9 indications for the Breast…

Breast Reference Set Application: Anu Mathew-Meso Scale (2012)

Using a subset of plasma samples (n=505) from the reference set, we analyzed 90 proteins by multiplexed immunoassays for their potential utility as diagnostic markers.

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Biomarker Characteristics Summary

No statistics found.

Decision Rule

No extra decision rule information available

Additional Study-Specific Protocols
Study-Specific Publications

No study-specific publications defined.

Study-Specific Resources

No study-specific resources defined.

Organ-Specific Protocols

No organ-specific protocols defined.

Organ-Specific Publications

No organ-specific publications defined.

Organ-Specific Resources

No organ-specific resources defined.

Ovary

Attributes

Phase: Three
QA State: Accepted

Overview

CA19-9 may be a molecular marker for ovarian cancer. Literature suggests that the concomitant measurement of CA19-9 with CA125 could offer some benefit in the monitoring of patients for the recurrence of ovarian carcinoma.

Performance Comment

Of the 28 ovarian cancer biomarkers tested in prediagnostic specimens, from the PLCO, CA125 remains the the single best biomarker for ovarian cancer and has its strongest signal within six months of diagnosis. CA19-9 alone was not a strong predictor.

Supporting Study Data

The following studies/protocols provide evidence supporting CA19-9 indications for the Ovary…

PLCO Ovarian Phase III Validation Study

Our preliminary data indicate that the performance of CA 125 as a screening test for ovarian cancer can be improved upon by additional biomarkers. With completion of one additional validation step, we will be ready to test the performance of a consensus marker panel in a phase III validation study. Given the original aims of the PLCO trial, we believe that the PLCO represents an ideal longitudinal cohort offering specimens for phase III validation of ovarian cancer biomarkers.

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Biomarker Characteristics Summary
Notes Sensitivity Specificity Prevalence NPV PPV Specific Assay Type
Cases chosen with diagnosis of ovarian cancer (on average) 9 months prior. Controls were matched to cases by age and timing of specimen collection including general population controls (50%), false positive CA125 (25%), and family history of breast cancer (25%). All cases (n=60). 12.0 95.0 N/A N/A N/A
Cases diagnosed <= 6 months after draw (n=25). 21.0 95.0 N/A N/A N/A
Cases diagnosed > 6 months after draw (n=35). 6.0 95.0 N/A N/A N/A
Decision Rule

PMID:21372037

Additional Study-Specific Protocols
Study-Specific Publications

No study-specific publications defined.

Study-Specific Resources

No study-specific resources defined.

SPORE/EDRN/PRE-PLCO Ovarian Phase II Validation Study

Create a new set of phase II specimens (160 cases with pre-operative bloods representing major histologic types and including 80 early-staged and 80 late-staged cases, 160 controls with benign disease, 480 general population controls, and a small set of serial Samples collected either at least 3 months apart, but not more than 6 months apart OR between 10 months apart and no more than 14 months apart in 40 healthy controls) will be used to evaluate markers identified in preliminary work. The top 5-10 markers, plus an expanded panel of Luminex markers, will comprise a “working consensus panel” for subsequent analysis in PLCO specimens.

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Biomarker Characteristics Summary
Notes Sensitivity Specificity Prevalence NPV PPV Specific Assay Type
For all cases, using all controls. Results from preliminary analysis, 50% of 114 sample set. Daniel Cramer laboratory. 12.0 95.0 N/A N/A N/A
For early stage (more than 12 months prior to diagnosis), using all controls. Results from preliminary analysis, 50% of 114 sample set. Daniel Cramer laboratory. 14.0 95.0 N/A N/A N/A
For late stage (within 12 months of diagnosis), using all controls. Results from preliminary analysis, 50% of 114 sample set. Daniel Cramer laboratory. 9.0 95.0 N/A N/A N/A
Cases chosen with diagnosis of ovarian cancer (on average) 9 months prior. Controls were matched to cases by age and timing of specimen collection including general population controls (50%), false positive CA125 (25%), and family history of breast cancer (25%). All cases (n=60). 12.0 95.0 N/A N/A N/A
Cases diagnosed <= 6 months after draw (n=25). 21.0 95.0 N/A N/A N/A
Cases diagnosed > 6 months after draw (n=35). 6.0 95.0 N/A N/A N/A
Decision Rule

PMID:21372037

Additional Study-Specific Protocols
Study-Specific Publications

No study-specific publications defined.

Study-Specific Resources

No study-specific resources defined.

Organ-Specific Protocols

No organ-specific protocols defined.

Organ-Specific Publications

Organ-Specific Resources

No organ-specific resources defined.

Pancreas

Attributes

Phase: One
QA State: Under Review

Overview

No data available.

Performance Comment

No data available.

Supporting Study Data

The following studies/protocols provide evidence supporting CA19-9 indications for the Pancreas…

Pancreatic Reference Set Application: Brian Haab-Van Andel (2012)

New markers are greatly needed for the detection and diagnosis of pancreatic cancer. Patients at high risk for developing pancreatic cancer (for, example because of genetic predisposition or health status) can be screened by endoscopy or a related imaging procedure, but these methods are expensive and burdensome to the patient. Blood-based markers would facilitate regular screening. In addition, patients with known abnormalities of the pancreas (for example, as observed incidentally from an abdominal scan) need to determine whether they have cancer or not. The great majority of patients with pancreatic findings by CT do not have conditions that require treatment, yet nearly all patients undergo invasive and burdensome procedures as a consequence of the CT. Again, a blood-based marker could alleviate this situation and potentially add accuracy to the diagnosis. In preliminary work we showed the potential for highly-accurate discrimination of pancreatic cancer from pancreatitis and healthy control subjects using a panel of protein and glycan markers in the serum. We used an antibody array platform in which we can obtain sensitive, reproducible measurements of protein abundance and glycosylation status in low sample volumes. The detection of the glycosylation status is important for the high accuracy of the test because the glycans attached to the marker proteins are altered in cancer patients. Based on the good performance in these early studies, we now want to validate the performance in rigorously controlled, blinded sample sets. The reference set developed by the EDRN will enable a definitive characterization of our marker performance. In addition, we can make an accurate comparison to other markers that will be applied to the same set and determine whether disparate markers could be used together for added benefit.

View more about this study
Biomarker Characteristics Summary

No statistics found.

Decision Rule

No extra decision rule information available

Additional Study-Specific Protocols
Study-Specific Publications

No study-specific publications defined.

Study-Specific Resources

No study-specific resources defined.

Organ-Specific Protocols

No organ-specific protocols defined.

Organ-Specific Publications

No organ-specific publications defined.

Organ-Specific Resources

No organ-specific resources defined.

Prostate

Attributes

Phase: One
QA State: Under Review

Overview

No additional data available.

Performance Comment

CD90 (THY1), AGR2, and CEACAM5 are all up-regulated in prostate cancer.

Supporting Study Data

The following studies/protocols provide evidence supporting CA19-9 indications for the Prostate…

Biomarkers for Prostate and Bladder Cancer

CD26+ cancer cells and CD90+ tumor-associated stromal cells were sorted from tumor tissue. Dataset analysis with transcriptomes of CD26+ luminal, CD104+ basal, CD49a+ stromal and CD31+ endothelial was carried out to identify candidates: CD90, AGR2, BCMP11, CEACAM5, CRISP3. Quantitative protomics was applied to measure these proteins in urine samples.

View more about this study
Biomarker Characteristics Summary

No statistics found.

Decision Rule

No extra decision rule information available

Additional Study-Specific Protocols
Study-Specific Publications

No study-specific publications defined.

Study-Specific Resources

No study-specific resources defined.

Organ-Specific Protocols

No organ-specific protocols defined.

Organ-Specific Publications

No organ-specific publications defined.

Organ-Specific Resources

No organ-specific resources defined.

Resources

External Resources for CA19-9


Gene

Protein

Other

No other associated resources found.

Biomuta

No associated Biomuta entries found.