About

Dr. Carolyn Compton is an academic pathologist specializing in gastrointestinal disease, with board certification in both anatomic and clinical pathology. She holds the position of Professor of Life Sciences at Arizona State University and is also a Professor of Laboratory Medicine and Pathology at the Mayo Clinic. Additionally, she serves as an adjunct professor of pathology at the University of Arizona and Johns Hopkins University. Her extensive career includes roles such as former professor of pathology at Harvard Medical School, chief of Gastrointestinal Pathology at Massachusetts General Hospital, and pathologist-in-chief of the Boston Shriners Children’s Hospital. She has served as CEO and president of the Critical Path Institute, director of Biorepositories and Biospecimen Research at the National Cancer Institute, and chair of the Department of Pathology at McGill University. Dr. Compton is actively involved in various professional organizations, including serving as chair of the Precision Medicine Core of the American Joint Committee on Cancer and chair of the Pre-analytics for Precision Medicine Project Team at the College of American Pathologists. She has authored over 500 scientific manuscripts, review articles, books, and chapters, contributing significantly to the fields of biomarker development, biobanking, and precision medicine.

Research topics

• Information Retrieval
• Computer Science
• Data Mining
• Internal medicine
• Genetics
• Pathology
• Gynecology
• Database
• Oncology
• Family medicine
• Medicine
• Intensive care medicine

Selected publications

• Recommended Clinical Context and Patient Context Data Elements for Liquid Biopsy Data Submitted to Data Repositories and Data Commons

  Clinical and Translational Science · 2025-04-01 · 2 citations

  articleOpen access

  In 2020, BLOODPAC recommended 11 pre-analytical minimal technical data elements for collection and submission of liquid biopsy data to public databases. This article expands on that work by recommending 22 clinical context and 10 patient context data elements. These elements, essential for liquid biopsy data submitted to repositories like the BLOODPAC Data Commons, cover tumor characteristics, disease progression, and patient demographics, supporting biomarker validation, research, and clinical trials.

  PublisherOA PDFDOI

• Development and Validation of EsoTIME, a Prognostication Tool for Resected Esophageal and Gastroesophageal Cancer

  Annals of Surgical Oncology · 2025-10-25

  article
  PublisherDOI

• Large-Scale Saliva-Based Clinical Surveillance Enables Real Time SARS-CoV-2 Outbreak Detection and Genomic Tracking (Arizona, 2020–2023)

  Diagnostics · 2025-10-21

  articleOpen access

  Background/Objectives: Monitoring community health and tracking SARS-CoV-2 evolution were critical priorities throughout the COVID-19 pandemic. However, widespread shortages of personal protective equipment, the necessity for social distancing, and the redeployment of healthcare personnel to clinical duties presented significant barriers to traditional sample collection. Methods: In this study, we evaluated the feasibility of using self-collected saliva specimens for the qualitative detection of SARS-CoV-2 infection. Following confirmation of reliable viral detection in saliva, we established a large-scale surveillance program in Arizona, USA, to enable clinical diagnosis and genomic sequencing from self-collected samples. Between April 2020 and December 2023, we tested approximately 1.4 million saliva samples using RT-PCR, identifying 94,330 SARS-CoV-2 infections. Whole genome sequencing was performed on 69,595 samples, yielding 54,040 high-quality consensus genomes. Results: This surveillance approach enabled real-time monitoring of general infection trends that matched regional case counts. We monitored multiple wave-like introductions of viral lineages over the course of the pandemic. We identified three periods of S gene target failure on a commercial assay and assessed its ability to make fast, genotyping assignment during the pandemic (PPV = 0.98, 95% CI = 0.97–0.99; NPV = 0.94, 95% CI = 0.94–0.96). The co-location of clinical testing and sequencing capabilities within the same facility resulted in low turnaround time from the sample collection to the generation of sequencing data (median = 12 days, IQR: 9.0–19.75). Conclusions: Our findings support the use of self-collected saliva as a scalable, cost-effective, and practical strategy for infectious disease surveillance in future pandemics.

  PublisherOA PDFDOI

• Clinical Surveillance Identifies SARS-CoV-2 Outbreaks and Emergence of Novel Variants in Real-Time

  medRxiv · 2025-09-11

  preprintOpen access

  Abstract Monitoring community health and tracking SARS-CoV-2 evolution were critical priorities throughout the COVID-19 pandemic. However, widespread shortages of personal protective equipment, the necessity for social distancing, and the redeployment of healthcare personnel to clinical duties presented significant barriers to traditional sample collection. In this study, we evaluated the feasibility of using self-collected saliva specimens for the qualitative detection of SARS-CoV-2 infection. Following confirmation of reliable viral detection in saliva, we established a large-scale surveillance program in Arizona, USA, to enable clinical diagnosis and genomic sequencing from self-collected samples. Between April 2020 and December 2023, we tested approximately 1.4 million saliva samples using RT-PCR, identifying 94,330 SARS-CoV-2 infections. Whole genome sequencing was performed on 69,595 samples, yielding 54,040 high-quality consensus genomes. This surveillance approach enabled real-time monitoring of infection trends, outbreak detection within specific populations, and the identification of novel viral lineages over the course of the pandemic. The co-location of clinical testing and sequencing capabilities within the same facility significantly reduced turnaround time from the identification of positive cases to the generation of sequencing data. Our findings support the use of self-collected saliva as a scalable, cost-effective, and practical strategy for infectious disease surveillance in future pandemics.

  PublisherOA PDFDOI

• ASO Visual Abstract: Development and Validation of EsoTIME, a Prognostication Tool for Resected Esophageal and Gastroesophageal Cancer

  Annals of Surgical Oncology · 2025-11-14

  article
  PublisherDOI

• Lexicon for Clonal Hematopoiesis in Liquid Biopsy

  Clinical and Translational Science · 2025-12-26 · 1 citations

  articleOpen access

  Historically, clonal hematopoiesis (CH) has been recognized as a confounder of cell-free DNA (cfDNA) testing. Recent evidence now demonstrates the role of CH as a risk factor in health, generating distinct sources of cfDNA that can be leveraged for liquid biopsy diagnostics. Nonetheless, gaps in standardization challenge the advancement of such diagnostics from development to regulatory approval, through clinical trials, and ultimately, to routine implementation. In 2024, the Blood Profiling Atlas in Cancer (BLOODPAC) Consortium, a collaborative infrastructure for developing standards and best practices for liquid biopsy assays, established the CH/clonal hematopoiesis of indeterminate potential (CHIP) Working Group to address the need for accurate identification and removal of CH from liquid biopsy results. As a first step to support the interpretability of CH/CHIP results, the Working Group developed this lexicon to standardize terms and provide a unified vocabulary related to CH and liquid biopsy, DNA sequencing tests, biomarkers, and clinical use cases, facilitating communication within the field. BLOODPAC's CH/CHIP Working Group believes that terminology agreement across these various stakeholders can improve communication in the field and unify future data collection efforts across studies.

  PublisherOA PDFDOI

• Towards Preanalytical Best Practices for Liquid Biopsy Studies: A BLOODPAC Landscape Analysis

  Clinical Pharmacology & Therapeutics · 2024-08-20 · 8 citations

  reviewOpen access

  BLOODPAC is a public-private consortium that develops best practices, coordinates clinical and translational research, and manages the BLOODPAC Data Commons to broadly support the liquid biopsy community and accelerate regulatory review to aid patient accessibility. BLOODPAC previously recommended 11 preanalytical minimal technical data elements (MTDEs) for BLOODPAC-sponsored studies and data submitted to BLOODPAC Data Commons. The current landscape analysis evaluates the overlap of the BLOODPAC MTDEs with current best practices, guidelines, and standards documents related to clinical and research liquid biopsy applications. Our findings indicate an existing high degree of concordance among these documents. Where differences exist, the BLOODPAC preanalytical MTDEs can be considered a minimal practicable set for organizations to utilize. These MTDEs were developed following extensive examination of best practices and iterative conversations with the U.S. FDA. BLOODPAC recommends the use of these MTDEs in submissions to data commons and to support liquid biopsy clinical trials and research globally.

  PublisherOA PDFDOI

• Supplementary Figures from Association of <i>TP53</i> Mutational Status and Gender with Survival after Adjuvant Treatment for Stage III Colon Cancer: Results of CALGB 89803

  2023-03-31

  preprintOpen access

  <p>Supplementary Figures - PDF file 341K, Figure S1. CALGB 89803 Consolidated Standards of Reporting Trials (CONSORT) diagram. Cancer and Leukemia Group B (CALGB) 89803 conducted a randomized trial of adjuvant therapy in patients with stage III colorectal cancers. The trial included prospective determination of the relationship between tumor TP53 mutational status, gender, and treatment outcome as a secondary study end point. CPT-11, irinotecan; FU, fluorouracil; LV, leucovorin. Figure S2. Kaplan-Meier estimates of disease-free survival related to TP53 status for men and women in CALGB 89803. A. DFS in the presence or absence of any TP53 mutation showed no differences among women (P = 0.16). B. Similarly, DFS in the presence or absence of any TP53 mutation showed no differences among men (P = 0.16). WT = wild type TP53; Mutant = any TP53 mutation in exons 5-8). Corresponding 5 year survival estimates are in Table 2, Rows 5 and 6. Figure S3. Kaplan-Meier estimates of disease-free survival related to TP53 status among men in CALGB 89803. Men whose tumors harbored wild-type (WT) TP53, or tumors with mutations in the zinc-binding (ZB) or non-zinc binding (NZB) domains of TP53 were treated with 5FU/LV (Figure S3A) or IFL (Figure S3B). No differences in survival according to TP53 genotype were observed among men treated with 5FU/LV (P = 0.65) or IFL, P = 0.14. Corresponding 5 year survival estimates are in Table 2, Rows 16-17. Figure S4. Kaplan-Meier estimates of disease-free survival related to TP53 status among women in CALGB 89803. Women whose tumors harbored wild-type TP53, or tumors with mutations in the zinc-binding (ZB) or non-zinc binding (NZB) domains of TP53 were treated with 5FU/LV or IFL. (A) Women with TP53 WT tumors experienced a statistically similar outcome on either treatment arm (P = 0.35. (B) Women whose tumors harbored ZB mutations may have benefited marginally from IFL as compared to 5FU/LV (P = 0.10). (C) Women whose tumors harbored NZB mutations experienced a trend toward better survival with 5FU/LV compared to IFL (P = 0.08)</p>

  PublisherDOI

• Data from Association of <i>TP53</i> Mutational Status and Gender with Survival after Adjuvant Treatment for Stage III Colon Cancer: Results of CALGB 89803

  2023-03-31

  preprintOpen access

  <div>Abstract<p><b>Purpose:</b> The <i>TP53</i> tumor suppressor is frequently mutated in colon cancer, but the influence of such mutations on survival remains controversial. We investigated whether mutations in the DNA-binding domain of <i>TP53</i> are associated with survival in stage III colon cancer.</p><p><b>Experimental Design:</b> The impact of <i>TP53</i> genotype was prospectively evaluated in Cancer and Leukemia Group B 89803, a trial that randomized stage III colon cancer patients to receive adjuvant 5-fluorouracil/leucovorin (5FU/LV) or 5FU/LV with irinotecan (IFL).</p><p><b>Results:</b><i>TP53</i> mutations were identified in 274 of 607 cases. The presence of any <i>TP53</i> mutation did not predict disease-free survival (DFS) or overall survival with either adjuvant regimen when men and women were considered together or as separate groups. However, outcome differences among women became apparent when tumor <i>TP53</i> genotype was stratified as wild-type versus zinc- or non-zinc-binding mutations in the <i>TP53</i> DNA-binding domain. DFS at 5 years was 0.59, 0.52, and 0.78 for women with <i>TP53</i> wild-type tumors, and tumors with zinc- or non-zinc-binding mutations, respectively. Survival at 5 years for these same women was 0.72, 0.59, and 0.90, respectively. No differences in survival by <i>TP53</i> genotype were observed in men.</p><p><b>Conclusions:</b> The presence of any <i>TP53</i> mutation within the DNA-binding domain did not predict survival in stage III colon cancer. However, <i>TP53</i> genotype was predictive of survival in women following adjuvant therapy. Future colon cancer therapeutic trials, with inclusion of correlative molecular markers, should be designed to permit evaluation of survival and/or response to treatment in women separately from men. <i>Clin Cancer Res; 19(20); 5777–87. ©2013 AACR</i>.</p></div>

  PublisherDOI

• Supplementary Figures from Association of <i>TP53</i> Mutational Status and Gender with Survival after Adjuvant Treatment for Stage III Colon Cancer: Results of CALGB 89803

  2023-03-31

  preprintOpen access

  <p>Supplementary Figures - PDF file 341K, Figure S1. CALGB 89803 Consolidated Standards of Reporting Trials (CONSORT) diagram. Cancer and Leukemia Group B (CALGB) 89803 conducted a randomized trial of adjuvant therapy in patients with stage III colorectal cancers. The trial included prospective determination of the relationship between tumor TP53 mutational status, gender, and treatment outcome as a secondary study end point. CPT-11, irinotecan; FU, fluorouracil; LV, leucovorin. Figure S2. Kaplan-Meier estimates of disease-free survival related to TP53 status for men and women in CALGB 89803. A. DFS in the presence or absence of any TP53 mutation showed no differences among women (P = 0.16). B. Similarly, DFS in the presence or absence of any TP53 mutation showed no differences among men (P = 0.16). WT = wild type TP53; Mutant = any TP53 mutation in exons 5-8). Corresponding 5 year survival estimates are in Table 2, Rows 5 and 6. Figure S3. Kaplan-Meier estimates of disease-free survival related to TP53 status among men in CALGB 89803. Men whose tumors harbored wild-type (WT) TP53, or tumors with mutations in the zinc-binding (ZB) or non-zinc binding (NZB) domains of TP53 were treated with 5FU/LV (Figure S3A) or IFL (Figure S3B). No differences in survival according to TP53 genotype were observed among men treated with 5FU/LV (P = 0.65) or IFL, P = 0.14. Corresponding 5 year survival estimates are in Table 2, Rows 16-17. Figure S4. Kaplan-Meier estimates of disease-free survival related to TP53 status among women in CALGB 89803. Women whose tumors harbored wild-type TP53, or tumors with mutations in the zinc-binding (ZB) or non-zinc binding (NZB) domains of TP53 were treated with 5FU/LV or IFL. (A) Women with TP53 WT tumors experienced a statistically similar outcome on either treatment arm (P = 0.35. (B) Women whose tumors harbored ZB mutations may have benefited marginally from IFL as compared to 5FU/LV (P = 0.10). (C) Women whose tumors harbored NZB mutations experienced a trend toward better survival with 5FU/LV compared to IFL (P = 0.08)</p>

  PublisherOA PDFDOI

Recent grants

• NIH Grant R01GM035242

  NIH · $567k · 1994

Frequent coauthors

• Donna Niedzwiecki

  Duke University

  308 shared

• Monica M. Bertagnolli

  275 shared

• Robert J. Mayer

  262 shared

• Richard M. Goldberg

  Applied Physical Sciences (United States)

  169 shared

• Robert S. Warren

  University of California, San Francisco

  158 shared

• Patrick L. Fitzgibbons

  St. Jude Medical Center

  155 shared

• Mark Redston

  Harvard University

  152 shared

• L P Fielding

  University of Hull

  133 shared

Education

• B.A.

  Bryn Mawr College

  1969

• M.D.

  Harvard Medical School

  1977

• Ph.D.

  Harvard Graduate School of Arts & Sciences

  1977

Awards & honors

• Aesulapian Society – Harvard Medical School (1972)
• President’s Award – College of American Pathologists (2000)
• Frank W. Harman Award – College of American Pathologists (20…
• Award of Merit – NIH (Group award for the Biorepository Coor…
• Award of Merit – NIH (Group award for the Biorepository and…