Biomarker Analysis for Gynecologic Cancers

(VENUS Trial)

Overseen By Amit Oza, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Previous treatment, High grade serous ovarian, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

In recent years, there has been a significant improvement in understanding the biology of cancer and this information has been used to improve cancer care and patient outcome. Research has shown that changes in some genes and/or proteins may be important indicators for certain cancers and response to treatments. Genes are molecules made up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for the development and functioning of the cells in the body and are passed down from parent to child. RNA is involved with producing proteins in the body. Further research is needed to better understand the changes found in cancer cells and how to target them to stop or reduce cancer growth. A drug that may be able to block certain specific cancer cell changes is called "targeted therapy". Different people with the same type of cancer receiving the same drug could have different responses to it. For example, one person may experience a reduction of their tumor while another person's cancer may worsen. The reason for this is still not well understood and could lie in gene changes. Understanding these changes may allow researchers to predict how treatments may work in guiding decisions around choice of drugs. The purpose of the study is to learn more about gene changes or protein expression (levels) of tumors to better understand the behavior of gynecological diseases and, if possible, better address participants' cancer care now or in the future.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it does require that participants have not received any previous treatment for their newly diagnosed disease.

Is the treatment generally safe for humans?

The research articles provided do not contain specific safety data for the treatment involving Lynparza or the procedures like blood draws and tumor tissue collection. However, these procedures are commonly used in clinical settings and are generally considered safe when performed by trained professionals. ^{1 2 3 4 5}

How does this treatment for gynecologic cancers differ from other treatments?

The treatment focuses on using blood-based biomarkers to improve diagnosis and personalization of therapy for gynecologic cancers, which is unique compared to traditional methods that may not utilize such biomarkers for early detection and treatment customization. ^{4 6 7 8 9}

Research Team

Amit Oza, MD

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

This study is for individuals with probable gynecological cancers (like ovarian, uterine, cervical) who are set to undergo surgery or radiation. Participants must understand the study and agree in writing, have a life expectancy of at least 3 months, be willing to provide tissue and blood samples for research, be 16 years or older, and have an ECOG Performance Status of 2 or less.

Inclusion Criteria

I am 16 years old or older.

I have a gynecological cancer and am confirmed for initial major surgery or radiation.

You are expected to live for at least three more months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Tumor tissue and blood samples are collected for molecular and immunological characterization

1-2 weeks

Analysis

Analysis of gene changes or protein expression levels to understand tumor behavior

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after sample collection and analysis

4 weeks

Treatment Details

Interventions

• Blood draws
• Tumor tissue collection
• Tumour tissue collection

Trial Overview The trial involves collecting tumor tissue during surgery and drawing blood from patients with gynecological cancers. Researchers aim to learn about gene changes or protein levels in tumors to improve understanding of cancer behavior and treatment responses.

Participant Groups

Group I: Tumor tissue and blood samples collection Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

The Swedish Cervical Cytology Biobank (SCCB) is a pioneering national initiative that collects and stores liquid-based gynecological cell samples from women in cervical cancer screening programs, with over 120,000 samples expected to be processed this year.

A standardized protocol for sample handling and storage has been developed through extensive literature review and collaboration, ensuring high-quality management and creating a valuable resource for cancer research linked to national registries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Swedish cervical cytology biobank: sample handling and storage process. Perskvist, N., Norman, I., Eklund, C., et al.[2016]

The PLCO cancer screening trial has created a valuable biorepository by collecting blood and tumor tissue samples from participants, which aids in understanding cancer causes and developing treatment strategies.

This biorepository is unique because it includes serial samples collected before cancer diagnosis, along with extensive epidemiological data, making it a rich resource for cancer research and biomarker identification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PLCO Biorepository: Creating, Maintaining, and Administering a Unique Biospecimen Resource. Carrick, DM., Black, A., Gohagan, JK., et al.[2020]

Incorporating viable tumor banking into cancer biobanking can enhance the utility of collected samples by allowing for the establishment of short-term cultures, cell lines, and patient-derived xenograft models, which are essential for functional studies.

The chapter provides practical procedures for processing and cryopreserving blood and tissue specimens, enabling researchers to expand their biobanking strategies to include viable materials for advanced analyses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Processing and Cryopreservation of Blood, Cancer Tissues, and Cancer Cells for Viable Biobanking. Chan, JA., Vercauteren, SM.[2022]

Endometrial cancer is the most common gynecological cancer, with its incidence expected to rise significantly due to factors like obesity and longer life expectancy, highlighting the urgent need for improved research and treatment strategies.

Harmonizing biobanking standards is crucial for enhancing the quality and reproducibility of research data, which will support the development of personalized diagnostics and therapies for endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enriching Personalized Endometrial Cancer Research with the Harmonization of Biobanking Standards. Adishesh, M., Hapangama, DK.[2020]

The endometrial sampling device proved to be a feasible tool for monitoring patients with endometrial cancer or atypical hyperplasia during follow-up visits, achieving a high sampling success rate of 95% in 43 procedures across 19 patients.

Histological results from the endometrial sampling device were comparable to those obtained through hysteroscopy in cases with thicker endometrial linings, indicating its effectiveness, although caution is advised for patients with thinner endometria, where results may differ.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of endometrial sampling device during the follow-up visit for the conservative treatment of endometrial cancer]. Zhou, R., Shen, DH., Wang, CH., et al.[2014]

A comprehensive proteomic analysis identified FAM83D as a potential biomarker for early stage, low-grade endometrial cancer, showing increased levels in patients' serum compared to benign controls.

The study suggests that FAM83D may be linked to poor clinical outcomes in endometrial cancer, highlighting its potential role in future diagnostics and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive serum proteomic analysis in early endometrial cancer. Uyar, DS., Huang, YW., Chesnik, MA., et al.[2021]

In a study of 28 patients with uterine serous cancer (USC), there was a high correlation of molecular biomarkers between biopsy and final pathology specimens, with agreement rates ranging from 67% to 100% for various biomarkers.

The findings suggest that preoperative diagnostic biopsies can effectively guide neoadjuvant targeted therapy in USC, as they reliably reflect the biomarker status seen in subsequent hysterectomy specimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular markers in uterine serous cancer: Correlation between endometrial biopsy and hysterectomy specimens. Lokich, E., Kole, M., Raker, C., et al.[2022]

A study involving 331 women identified specific blood-based biomarkers that could effectively distinguish endometrial carcinoma (EC) from benign conditions and breast cancer, with malonylcarnitine showing the highest accuracy (AUC: 0.827).

Tryptophan was particularly effective in differentiating benign uterine lesions from endometrial carcinoma, indicating that these biomarkers could serve as potential screening tools for early detection of EC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of blood-based biomarker approaches in endometrium and breast cancer: a case-control comparison study. Schuhn, A., Tobar, TW., Gahlawat, AW., et al.[2022]

A consensus was reached among 40 stakeholders in endometrial cancer research on standardized tools for the collection, processing, and storage of biospecimens, which is crucial for ensuring the reliability of scientific data.

The developed tools are freely available and aim to enhance collaboration and efficiency in endometrial cancer research, potentially accelerating advancements in understanding and treating this common gynecological cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harmonisation of biobanking standards in endometrial cancer research. Adishesh, M., Fyson, A., DeCruze, SB., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Swedish cervical cytology biobank: sample handling and storage process. [2016]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The PLCO Biorepository: Creating, Maintaining, and Administering a Unique Biospecimen Resource. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Processing and Cryopreservation of Blood, Cancer Tissues, and Cancer Cells for Viable Biobanking. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Enriching Personalized Endometrial Cancer Research with the Harmonization of Biobanking Standards. [2020]

5. China pubmed.ncbi.nlm.nih.gov

[Application of endometrial sampling device during the follow-up visit for the conservative treatment of endometrial cancer]. [2014]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comprehensive serum proteomic analysis in early endometrial cancer. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Molecular markers in uterine serous cancer: Correlation between endometrial biopsy and hysterectomy specimens. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Potential of blood-based biomarker approaches in endometrium and breast cancer: a case-control comparison study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Harmonisation of biobanking standards in endometrial cancer research. [2018]