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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore gene and protein changes in gynecological cancers to better understand how these diseases behave and respond to treatments. Participants will provide blood and tumor tissue samples, helping researchers identify specific changes that could predict treatment effectiveness. This research could lead to improved cancer care in the future. It suits individuals diagnosed with gynecological cancers, such as uterine or cervical cancer, who are scheduled for surgery or radiation and have not received prior treatment. As an unphased trial, this study offers participants the chance to contribute to foundational research that could shape future cancer treatments.

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.

What prior data suggests that this biomarker analysis is safe for participants?

Research shows that understanding changes in genes and proteins in cancer cells can improve cancer treatment. In this trial, researchers collect blood and tumor tissue samples to learn more about cancer behavior.

Since the study involves collecting samples rather than testing a new drug, there are no new risks from experimental treatments. The main activity, sample collection, is generally safe. This means there are no new concerns about treatment effects on the body in this study. Participants will only undergo standard procedures like blood draws and tissue collection.

Why are researchers excited about this trial?

Researchers are excited about the biomarker analysis for gynecologic cancers because it offers a new way to understand and fight these diseases. Unlike traditional treatments that focus on directly attacking tumors through surgery, chemotherapy, or radiation, this approach uses blood and tumor tissue samples to identify specific biomarkers. These biomarkers can reveal unique characteristics of the cancer, potentially leading to more personalized and effective treatment strategies. By enabling a deeper understanding of the cancer's biology, this method could lead to more targeted therapies, reducing side effects and improving outcomes for patients.

What evidence suggests that this trial's methods could be effective for gynecologic cancers?

Research has shown that changes in genes and proteins can signal certain cancers and their response to treatments. Genes contain instructions for cell function, and any alterations can affect cancer growth. Proteins, produced by genes, can also change in cancer. By studying these changes through tumor tissue and blood samples in this trial, researchers aim to predict treatment effectiveness. This method, known as "targeted therapy," seeks to block changes in cancer cells, though its success varies among individuals. A better understanding of gene and protein changes may lead to improved cancer treatments in the future.

Who Is on the Research Team?

Amit Oza, MD

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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 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]

Citations