Can Hemoglobin be used to detect and monitor breast cancer progression? An A1C adapted POC test (ISSN 2753-8176 (online))

Can Hemoglobin be used to detect and monitor breast cancer progression? An A1C adapted POC test (ISSN 2753-8176 (online))

1.Ana Pedro

1.Gwyntwr1386 Health & Social Care, 592 Old Chester Road, Birkenhead, CH42 4NW, info@gwyntwr1386.com

Background and Rationale

Haemoglobin is a protein which is present in red blood cells and that is responsible for carrying oxygen from the lungs to body tissues and also for returning carbon dioxide from tissues to the lung. Low levels of hemoglobin (anemia) might be associated with cancer.

A role for haemoglobin in cancer diagnosis in general is supported by a good number of publications. A previous work indicated the possibility of a direct relationship between the hemoglobin level and not only the early stages of cancer, but also the chemically induced precancerous condition (1). Interestingly, in patients with a diagnosis of primary lung, colorectal, breast or liver cancer, higher post-diagnosis haemoglobin change regardless of the baseline haemoglobin levels and the direction of changes associates with a significantly shorter survival (2).Here we summarize, the results of our findings in what concerns proteomics analyzis of several different cancer patient samples and of cancer cell lines and cancer models for several different hemoglobin subunits and variants.

Breast cancer

Preliminary data of our lab have showed that we have identified a biomarker for early stage ER+ breast cancer, HCG1745306 isoform CRA-a (3).Additional published data from our lab shows that hemoglobin subunit alpha (HBA1), which was found to be present in urine samples of patients with early breast cancer (BC) (4), also presents very high mascot scores in plasma samples of patients with early BC. The mascot scores, however, drop in the plasma of patients with locally advanced BC and of patients with certain metastatic patterns. Also, HBA1 is not significantly present in the primary BC tumor tissues, although bone metastases, show a high score for this protein. Hemoglobin subunit beta (HBB), which was found to increase breast cancer cells aggressiveness and associates with poor prognosis (5), also presents very high mascot scores (*) in plasma samples of patients with early BC. The mascot scores, however, drop in the plasma of patients with locally advanced BC, but are significant in the primary BC tissues what allows us to think might be secreted by the tumor. Bone metastases, also show a high score for this protein (6).

Aims and Objectives

To evaluate the outcomes of the proposed HB clinical trial towards developing a new blood-based test to detect and monitor breast cancer.

Methodology/ Plan

1. Project design and methods

We propose to collect around 50 WB samples from patients with different types of breast cancer in early and advanced stages and 50 WB samples from healthy controls (in agreement with table 1), analyze for with A1C Now+ device for concentrations of different hemoglobin subunits and to develop a new A1C Now + device which will detect and differentiate among different types and stages of breast cancers. Patient and controls WB samples will be collected from patients and health volunteers.

2. Timelines and milestone

Work Packages

Work Package 1 - IRAS application

Application with IRAS for the clinical trial

Work Package 2 - Samples collection

Collect and store patients and controls blood samples linking to clinical history.

Work Package 3 - ELISA study and validation

Analyse with the A1C Now + device the presence of different HB subunits in the blood samples of patients and controls Statistics

Number of participants

50 patients control arm + 50 patients study arm

Sample sizes between 24 and 50 have been recommended (Lancaster et al. 2004; Sim & Lewis, 2012; Julious, 2005. With a sample of 50, we will use a 95% confidence interval.

Work Package 4 - Data analysis

Analyse data obtained in order to apply for funding to conduct a larger randomized controlled trial involving across the UK.

References

1. Taylor A, Pollack, MA. Hemoglobin Level and Tumor Growth. Cancer Research (1942)2. BMC Cancer. 2013 Jul 10;13:340. doi: 10.1186/1471-2407-13-340.Post-diagnosis hemoglobin change associates with overall survival of multiple malignancies - results from a 14-year hospital-based cohort of lung, breast, colorectal, and liver cancers. Wan S, Lai Y, Myers RE, Li B, Palazzo JP, Burkart AL, Chen G, Xing J, Yang H.

3. Tucker R, Pedro A. Blood-derived non-extracellular vesicle proteins as potential biomarkers for the diagnosis of early ER+ breast cancer and detection of lymph node involvement. Version 3. F1000Res. 2018 Mar 6 [revised 2018 May 10];7:283. doi: 10.12688/f1000research.14129.3. eCollection 2018.

4. Beretov J, Wasinger VC,Millar EK, Schwartz P, Graham PH, Li Y.Proteomic Analysis of Urine to Identify Breast Cancer Biomarker Candidates Using a Label-Free LC-MS/MS Approach. PLoS One. 2015 Nov 6;10(11):e0141876. doi: 10.1371/journal.pone.0141876.

5. Non-conventional role of haemoglobin beta in breast malignancy. British Journal of Cancer (2017) 117, 994–1006 | doi: 10.1038/bjc.2017.247. Marco Ponzetti

6. Pedro A (2022). Hemoglobin as a biomarker for breast cancer ISSN 2753-8176 (online) (DOI: 10.13140/RG.2.2.25461.65764)

7. Pedro A (2022). Hemoglobin as a biomarker for melanoma - short report DOI: 10.13140/RG.2.2.32520.29445, ISSN 2753-8176 (online)

8. Pedro A (2022). Hemoglobin in colorectal cancer (DOI: 10.13140/RG.2.2.32515.99363, ISSN 2753-8176 (online))

9. Pedro A (2023).Hemoglobin in gastric cancer (ISSN 2753-8176 (online), DOI:10.1101/202291v1 , Small report

10. Pedro A (2023).Hemoglobin in Lung Cancer - Short report (ISSN 2753-8176 (online), DOI: 10.13140/RG.2.2.30186.59842

11.Pedro A (2023).Hemoglobin in Head and Neck cancer - Short report (ISSN 2753-8176 (online), DOI: 10.13140/RG.2.2.16792.67846

12. Pedro A (2023).Hemoglobin and osteoblasts markers in bone cancer, ISSN 2753-8176 (online), DOI: 10.13140/RG.2.2.14509.05606

13. Pedro A (2023).Hemoglobin and Children’s cancers - Brief Report, DOI: 10.13140/RG.2.2.21321.52325, ISSN 2753-8176 (online)14. Pedro A (2023).Hemoglobin in Acute Leukemias - Brief report , ISSN 2753-8176 (online)

(*) https://www.matrixscience.com/help/scoring_help.html

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