Biospecimen Collection for Breast Cancer

Overseen By Nicole L. Simone

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Under 18, Drug/alcohol abuse

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

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to collect samples from people with breast cancer to better understand the disease and improve future treatments. Participants will provide a tissue sample during a scheduled surgery, along with a blood sample (also known as venipuncture or phlebotomy) and, optionally, a rectal swab for biome (community of microorganisms) analysis. The trial seeks individuals with breast cancer who are undergoing surgery for tumor removal, receiving a vascular access device before starting treatment, or having brain surgery due to cancer spread. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to better treatments for breast cancer in the future.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely since the trial involves collecting tissue and blood samples during a procedure you are already scheduled for.

What prior data suggests that these procedures are safe?

Research has shown that collecting blood and tissue samples is generally safe and well-tolerated. These procedures are common in medical care, with many people having blood drawn regularly without issues. The rectal swab is optional and similar to tests often performed in doctor's offices.

Most people do not experience problems with these types of sample collections. Any discomfort is usually mild and short-lived. For instance, blood draws might cause a small bruise or slight soreness at the site. The rectal swab might feel a bit uncomfortable, but the sensation doesn't last long.

In summary, these procedures are safe as they are part of regular medical care. The trial primarily observes outcomes using methods already considered safe.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on collecting biospecimens like blood, tissue, and rectal swabs from breast cancer patients, which could provide valuable insights into the disease. Unlike standard diagnostic methods that primarily rely on imaging and biopsies, this approach aims to gather comprehensive biological data that might help in understanding cancer progression and treatment response. By analyzing these specimens, scientists hope to uncover new biomarkers and improve personalized treatment strategies, potentially leading to more effective and targeted therapies in the future.

What evidence suggests that this trial's procedures could be effective for breast cancer?

This study involves collecting blood, tissue, and possibly rectal swab samples from patients already undergoing standard procedures for breast cancer. It does not test a new treatment but aims to gather information to better understand the disease. The samples collected may help researchers learn more about how breast cancer starts and spreads. Although this study does not treat breast cancer, the information gathered could lead to better treatments in the future. No data on effectiveness exists because this is not a treatment trial.

Who Is on the Research Team?

Nicole L. Simone

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with breast cancer, including carcinoma in situ or invasive types, who can consent to participate. They must be scheduled for surgical tumor removal, vascular access device placement before neoadjuvant therapy, or neurosurgical resection of a brain metastasis from primary breast cancer.

Inclusion Criteria

I have been diagnosed with breast cancer, either non-invasive or invasive.

I can make my own medical decisions or have someone who can.

I am having surgery for breast cancer or to prepare for its treatment.

Exclusion Criteria

I am under 18 years old.

I cannot give consent and do not have someone to do it for me.

You currently have a problem with drugs or alcohol, or have had a history of problems with them.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard of Care Procedure

Tissue procurement during a standard of care procedure, a one-time blood draw, and optional rectal swab for biome analysis

1 day

1 visit (in-person)

Follow-up

Follow-up will consist of chart review to determine date of recurrence, metastases, and/or death

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Blood Sample Collection
• Rectal Swab
• Tissue Sample Collection

Trial Overview The study involves collecting tissue during standard surgery, a one-time blood draw, and an optional rectal swab for biome analysis. The follow-up consists only of reviewing medical records to track recurrence, metastases, or death.

How Is the Trial Designed?

Group I: Standard of Care Experimental Treatment 3 Interventions

patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

The development of a web-based biosample register at the Medical University of Innsbruck aims to enhance the quality and accessibility of biospecimen data, which is crucial for clinical research.

By utilizing a standardized description model based on the MIABIS dataset, the register is expected to improve scientific collaboration and research quality through better organization and sharing of biosample collection information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A concept of a MIABIS based register of biosample collections at the Medical University of Innsbruck. Hofer, P., Fiegl, H., Angerer, J., et al.[2014]

Standardizing blood collection procedures is crucial for ensuring reproducibility in biomarker research, as blood is a key biospecimen used in biobanking.

The review outlines optimal methods for blood procurement and storage, highlighting the importance of using appropriate vacutainer tubes and conditions for both short- and long-term sample preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procurement, Storage, and Use of Blood in Biobanks. Perry, JN., Jasim, A., Hojat, A., et al.[2020]

Biobanks are defined as large collections of human biological materials linked to personal and health information, essential for health and medical research, and must adhere to ethical and legal standards as outlined by the International Organization for Standardization (ISO 20387:2018).

The review discusses the principles of biobanking, including definitions, classification, standardization, and ethical requirements, while also highlighting the evolution of biobanking practices, particularly in cancer research, and the infrastructure needed for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic principles of biobanking: from biological samples to precision medicine for patients. Annaratone, L., De Palma, G., Bonizzi, G., 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]

Blood specimens are crucial for cancer research, and their collection, processing, and storage must follow standardized procedures to ensure quality and reliability in studies.

Factors such as temperature during shipping, processing methods like cryopreservation, and storage conditions are vital for maintaining the integrity of blood samples for various laboratory analyses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood collection, shipment, processing, and storage. Vaught, JB.[2006]

Collecting blood samples from a site 15 cm distal to an intravenous infusion line does not affect the accuracy of blood test results, making it a safe option for clinical investigations.

In a study involving simultaneous blood sample collection from 41 tests, no significant differences were found between samples taken from the distal site and the opposite arm, indicating reliable data can be obtained without distressing the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental Research of Blood Collected From the Peripheral Side of the Fluid Infusion Site That Is Not Affected by Fluid Infusion. Koike, S., Takeda, T.[2022]

A significant majority of cancer patients in the study (87.1% for tissue and 83.3% for blood) expressed willingness to donate leftover samples for research, indicating strong support for biospecimen collection in cancer research.

Factors such as gender, age, first hospitalization, and education level influenced patients' willingness to donate, suggesting that targeted education efforts could enhance participation in biobanking activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes and Perceptions of Cancer Patients Toward Biospecimen Donation for Cancer Research: A Cross-Sectional Survey Among Chinese Cancer Patients. He, N., Guo, Y., He, M., et al.[2018]

Biological resource centres play a crucial role in the collection, processing, and storage of biological samples, which are essential for research, particularly in fields like cancer studies.

Effective management of biological samples requires careful planning regarding sample types, processing protocols, and storage conditions, all supported by a robust quality management system to ensure sample integrity and reliability for research outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological sample collection, processing, storage and information management. Vaught, JB., Henderson, MK.[2022]

The proposal emphasizes the need for standardized collection of biospecimens in neoadjuvant breast cancer trials to improve the quality and integration of research results across different studies.

It suggests specific timing for tumor tissue and blood sample collection, advocating for a single biopsy procedure to streamline the process for patients and enhance participation in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types. Loi, S., Symmans, WF., Bartlett, JM., et al.[2014]

Tumour biobanks play a crucial role in scientific research by systematically collecting, storing, and distributing biological samples and data, ensuring they are accessible for investigation.

Pathologists are essential in selecting samples for biobanks, and standard operating procedures must be harmonized to ensure compatibility across different biobanks, while ethical and legal considerations are addressed through Material Transfer Agreements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Organisation and use of a tumour tissue bank]. Fabian, P., Nenutil, R.[2018]

There is a significant shortage of high-quality, well-annotated cancer biospecimens, which are crucial for advancing drug discovery in oncology.

Biobanking is becoming more organized and professional, with the establishment of networks to share resources and improve quality management, which is essential for supporting personalized medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biobanking: the foundation of personalized medicine. Hewitt, RE.[2022]

The tumor biobank at the University of Siena has been crucial for cancer research since 1985, collecting a diverse range of biological samples such as DNA, RNA, tissues, and blood to enhance patient care.

This extensive collection of samples and clinical data supports the development of new strategies for cancer treatment, highlighting the importance of biobanks in advancing oncological research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a tumor bank: a thirty years experience of the University of Siena (Italy). Corso, G., Garosi, L., Marrelli, D., et al.[2015]

Citations