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CA15-3

Basics

Aliases:
This biomarker is also known as:
  • MCKD,
  • Cancer Antigen 15-3,
  • Carcinoma-Associated Mucin,
  • Polymorphic Epithelial Mucin,
  • Mucin 1, Cell Surface Associated,
  • DF3 Antigen,
  • Peanut-Reactive Urinary Mucin,
  • Tumor-Associated Epithelial Membrane Antigen,
  • Krebs Von Den Lungen-6,
  • MCKD1,
  • MUC-1,
  • CD227,
  • ADMCKD,
  • Tumor Associated Epithelial Mucin,
  • MUC1/ZD,
  • MUC-1/SEC,
  • MAM6,
  • PEM,
  • ADMCKD1,
  • MUC1,
  • H23 Antigen,
  • Medullary Cystic Kidney Disease 1 (Autosomal Dominant),
  • CA 15-3,
  • Mucin-1,
  • PEMT,
  • KL-6,
  • EMA,
  • Tumor-Associated Mucin,
  • Medullary Cystic Kidney Disease, Autosomal Dominant,
  • PUM,
  • MCD,
  • Episialin,
  • Breast Carcinoma-Associated Antigen DF3,
  • Mucin 1, Transmembrane,
  • CD227 Antigen,
  • CA15.3,
  • MUC-1/X,
  • H23AG,

View in BioMuta

Description…

From NCBI Gene: This gene encodes a membrane-bound protein that is a member of the mucin family. Mucins are O-glycosylated proteins that play an essential role in forming protective mucous barriers on epithelial surfaces. These proteins also play a role in intracellular signaling. This protein is expressed on the apical surface of epithelial cells that line the mucosal surfaces of many different tissues including lung, breast stomach and pancreas. This protein is proteolytically cleaved into alpha and beta subunits that form a heterodimeric complex. The N-terminal alpha subunit functions in cell-adhesion and the C-terminal beta subunit is involved in cell signaling. Overexpression, aberrant intracellular localization, and changes in glycosylation of this protein have been associated with carcinomas. This gene is known to contain a highly polymorphic variable number tandem repeats (VNTR) domain. Alternate splicing results in multiple transcript variants.[provided by RefSeq, Feb 2011]

Attributes

QA State: Accepted
Type: Protein
Short Name:
HGNC Name: MUC1

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 CA15-3 indications for the Breast…

No supporting studies or protocols found.

Organ-Specific Protocols

No organ-specific protocols defined.

Organ-Specific Publications

No organ-specific publications defined.

Organ-Specific Resources

No organ-specific resources defined.

Lung

Attributes

Phase: Two
QA State: Under Review

Overview

Performance Comment

Supporting Study Data

The following studies/protocols provide evidence supporting CA15-3 indications for the Lung…

No supporting studies or protocols found.

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

CA15-3 may be a molecular marker for ovarian cancer. Literature suggests that the concomitant measurement of CA15-3 with CA125 could be advantageous in the pre-operative discrimination of benign and malignant ovarian tumors.

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. CA15-3 alone was not a strong predictor.

Supporting Study Data

The following studies/protocols provide evidence supporting CA15-3 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.

View more about this study
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). 22.0 95.0 N/A N/A N/A
Cases diagnosed <= 6 months after draw (n=25). 46.0 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.

View more about this study
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. 24.0 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. 31.0 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. 14.0 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). 22.0 95.0 N/A N/A N/A
Cases diagnosed <= 6 months after draw (n=25). 46.0 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.

2016 EDRN PI Orientation

The New and Continuing EDRN Principal Investigator Orientation will take on a date and location to be determined.