Quest for Pan-Cancer Diagnosis/Prognosis Ends with HrC Test Measuring Oct4A in Peripheral Blood

Abstract

Cancer is a devastating disease whose incidence has increased in recent times and early detection can lead to effective treatment. Existing detection tools suffer from low sensitivity and specificity, and are high cost, invasive and painful procedures. Cancers affecting different tissues, ubiquitously express embryonic markers including Oct-4A, whose expression levels have also been correlated to staging different types of cancer. Cancer stem cells (CSCs) that initiate cancer are possibly the ‘transformed’ and pluripotent very small embryonic-like stem cells (VSELs) that also express OCT-4A. Excessive self-renewal of otherwise quiescent, pluripotent VSELs in normal tissues possibly initiates cancer. In an initial study on 120 known cancer patients, it was observed that Oct-4A expression in peripheral blood correlated well with the stage of cancer. Based on these results, we developed a proprietary HrC scale wherein fold change of OCT-4A was linked to patient status – it is a numerical scoring system ranging from non-cancer (0–2), inflammation (>2–6), high-risk (>6–10), stage I (>10–20), stage II (>20–30), stage III (>30–40), and stage IV (>40) cancers. Later the scale was validated on 1000 subjects including 500 non-cancer and 500 cancer patients. Ten case studies are described and show (i) HrC scale can detect cancer, predict and monitor treatment outcome (ii) is superior to evaluating circulating tumor cells and (iii) can also serve as an early biomarker. HrC method is a novel breakthrough, non-invasive, blood-based diagnostic tool that can detect as well as classify solid tumors, hematological malignancies and sarcomas, based on their stage.

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Acknowledgements

We would like to acknowledge Dr. AnantBhushan Ranade, Dr. Amit Bhatt and Dr. Rucha Dasare from Avinash Cancer Clinic for their generous support and for aiding in designing the clinical trial.

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Authors

Contributions

AR, AB and RD recruited subjects and reviewed the paper. DB wrote sections of the paper and reviewed it. VKT, AV and PP reviewed the paper. SC, VT performed laboratory experiments, analysed the data and reviewed the paper. NS reviewed the paper and drafted sections. BC performed statistical analysis. AT wrote sections as well as reviewed the paper.

Corresponding author

Correspondence to Ashish Tripathi.

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Ethics Approval

Ethics approval from Ethics Committee of Maharashtra Technical Education Society at Sanjeevan Hospital, Pune, India and was registered with Clinical Trial Registry India (CTRI/2019/01/017166).

Consent to Participate

Informed consent was obtained from all individual participants included in the study.

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Patients signed informed consent regarding publishing their data.

Conflict of Interest

The HrC scale was co-developed by Epigeneres Biotech. The pilot clinical study was sponsored by Epigeneres Biotech. The IP for the technology is owned by 23Ikigai.

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Highlights

• Cancers ubiquitously express embryonic marker Oct-4A, whose expression levels are related to stages of cancer.

• Cancer is initiated by the excessive self-renewal of very small embryonic-like stem cells (VSELs) that express Oct-4A.

• We developed a proprietary HrC scale wherein fold change of OCT-4A was linked to patient status.

• HrC scale can effectively screen, diagnose and prognose cancer with 100% sensitivity and specificity.

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Tripathi, V., Bhartiya, D., Vaid, A. et al. Quest for Pan-Cancer Diagnosis/Prognosis Ends with HrC Test Measuring Oct4A in Peripheral Blood. Stem Cell Rev and Rep (2021). https://doi.org/10.1007/s12015-021-10167-1

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Keywords

  • Cancer diagnosis
  • HrC
  • VSELs
  • Oct4A.