Patient Derived Preclinical Models

Cancer Clinical Trial

Official title:

Patient Derived Preclinical Models

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324553
• Other study ID #: 21-008831
• Secondary ID: NCI-2022-02445
• Status: Recruiting
• Start date: April 6, 2022
• Est. completion date: March 31, 2028

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study goal is to collect tumor specimens that may inform cancer biology to eventually improve outcomes for patients with cancer. This proposal represents a highly collaborative effort to support cancer research with the goal of developing novel therapeutic strategies using patient derived preclinical models. This study is being done to collect samples of tumor tissues, matched normal tissue when possible, and approximately 50 mL of blood.

Description:

The objective of this study is to collect tumor specimens (tumor tissues, matched normal tissue when possible, and 50 mL of blood) that may inform cancer biology to eventually improve outcomes for patients with cancer. Additionally, relevant specimens that were previously collected under an IRB approved protocol (13-000942), will be used with approval of the PI of that protocol and patient consent for participation in this protocol. The collected tissue specimens will be used to develop preclinical models; i.e., cell lines, patient derived micro-cancer models as well as patient-derived xenograft models. In this study we may profile tumors using genomic and/or proteomic approaches to identify targetable alterations in tumor tissue from patients. To assure that the derived cell lines and micro-cancer models have not been cross contaminated during development with other models in development, DNA sequencing may be used. Using these preclinical models, we will test new therapies in vitro, or in vivo in mice in order to identify novel therapeutics as well as interrogate genes for their role in tumor biology. Guidance for molecular targeted therapy will involve gene analysis of oncogenes and tumor suppressor genes. Results from these studies may provide the rationale for the design of future novel clinical trials. The evaluation of these preclinical models may lead to predictive value related to patient response to therapy as well as clinical trials. With consent, these models may be shared with other investigators internal or external to Mayo Clinic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age and older
• Patient is a good medical candidate for a standard of care or research biopsy or surgical procedure to obtain tissue

Exclusion Criteria:

• Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
• Institutionalized or incarcerated patients
• Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use
• Biopsy must not be considered more than minimal risk to the patient.
• Have a contraindication to percutaneous biopsy including:

1. Significant coagulopathy that cannot be adequately corrected.

2. Severely compromised cardiopulmonary function or hemodynamic instability.

3. Lack of a safe pathway to the lesion per the interventional radiologist.

4. Inability of the patient to cooperate with, or to be positioned for, the procedure.

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• Tissue Collection
Research tissue specimen will be obtained during the patient's clinical biopsy or clinical tumor resection, if feasible.

Diagnostic Test:
• Blood Collection
Up to 50 mL of research blood will be drawn around the time of the procedure. Additional blood may be collected in selected cases, as warranted, to monitor disease recurrence/remission or perform additional
• Buccal Swab
Buccal swab may be requested, if necessary, to generate germline data.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants accrued with genomic, microbiome, and drug sensitivity components of aggressive cancer.	Sequencing data from DNA and RNA will be integrated into a visualization platform to allow individualized study of patient tumor mutations, rearrangements, and RNA expression. Genomically informed analysis will be employed to select potential targets for drug screening in the patient-derived 3D models and determine how many specimens are able to grow as 3D models. In some cases, immunostain results may be analyzed for correlation to RNA expression levels.	Up to 6 years post tissue and blood collection
Secondary	Determine number of participants with genomic, microbiome and drug sensitivity assays (profile or functional) that suggest changes to treatment plan.	Sequencing data from DNA and RNA will be integrated into a visualization platform to allow individualized study of patient tumor mutations, rearrangements, and RNA expression. Genomically informed analysis will be employed to select potential targets for drug screening in the patient-derived 3D models. In some cases, immunostain results may be analyzed for correlation to RNA expression levels.	Up to 6 years post tissue and blood collection