Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors

NCT01987726 | Completed DMC

• 2 other identifiers: OSU-12067NCI-2013-00872
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies comprehensive gene sequencing in guiding treatment recommendations in patients with metastatic or recurrent solid tumors. Studying samples of blood and tissue from patients with cancer in the laboratory may improve the ability to plan treatment.

Conditions

Recurrent Breast Cancer; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Breast Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer

Keywords

Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (5)

• Feasibility of NGS on metastatic solid tumor tissue, in terms of number of patients screened, FMI test attempted, FMI test successful, and FMI tests results released to physicians

  Summary tables will be generated.

  Up to 18 months

• Feasibility of NGS result-based non-FDA-approved treatment plan, measured by reasons for ability or inability to receive an anti-cancer agent

  Summary tables will be generated.

  Up to 18 months

• Availability of recommended experimental regimens via clinical trials

  Up to 18 months

• Proportion of patients who have one recommended therapy

  The proportion of patients who have one recommended therapy recommended will be assessed and compared with the proportion who have multiple options recommended. Summarized, and estimates derived along with corresponding 95% confidence intervals.

  Up to 18 months

• Proportion of patients who have multiple options recommended

  The proportion of patients who have one recommended therapy recommended will be assessed and compared with the proportion who have multiple options recommended. Summarized, and estimates derived along with corresponding 95% confidence intervals.

  Up to 18 months

Secondary Outcomes (1)

• Presence of any oncogene or tumor suppressor gene mutations or amplifications identified by NGS on tumor tissue in each cohort

  Up to 18 months

Study Arms (1)

Observational (NGS, FMI testing)

PART I: Within 10 weeks of beginning a treatment regimen, tumor tissue samples, Blood Collection and CTCs(Circulating tumor cell)from patients are collected for NGS and FMI testing, respectively. Patients remain on current line of therapy until a change in treatment is warranted. The physician's treatment recommendation is documented prior to the release of the FMI results. PART II: Physicians are furnished with FMI test results when patients become eligible for a change in therapy and new treatment recommendations are documented. Treatment is dependent on preferences of the physician, patient, and/or results of the FMI test.

Other: cytology specimen collection procedure; Other: laboratory biomarker analysis

Interventions

cytology specimen collection procedure OTHER

Undergo collection of CTCs for NGS and FMI testing, respectively.The most recent tumor sample collected from the patient with enough tissue to perform NGS testing will be selected. Tumor from a metastatic or recurrent cancer lesion is preferred but not required. Tumor collection is for standard of care purposes and thus not detailed in this protocol.For each tissue specimen, a representative H\&E stained section will be evaluated by a qualified pathologist to confirm the histopathological diagnosis of cancer and to make a quantitative estimate of the proportion of the specimen that is tumor-related cells and the proportion that is non-tumor cells.

Also known as: cytologic sampling

Observational (NGS, FMI testing)

laboratory biomarker analysis OTHER

2 tubes of 7.5 mL blood samples each will be collected at time tumor tissue is sent to FMI and sent to Cynvenio Biosystems, Inc for CTC isolation and analysis. Patient CTCs will be recovered using Cynvenio CTC flow cell technology (Cynvenio Biosystems, Inc.) and enumerated using a combination of CD45, DAPI and cytokeratin staining.1 DNA will be isolated from CTCs and amplified using Φ-29 whole genome amplification (GE Healthcare). Sequencing to be performed by FoundationOne™ protocol.

Also known as: Correlative studies, blood samples

Observational (NGS, FMI testing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with recurrent or metastatic a solid tumor cancer.

You may qualify if:

• Are able to understand and provide written informed consent (most recent patient informed consent form) prior to initiation of any study-specific procedures
• Patients are diagnosed with recurrent or metastatic a solid tumor cancer; the first patients to be enrolled will have a diagnosis of breast cancer (Cohort 1) or colorectal cancer (Cohort 2)
• Patients may enter this study at any line of therapy
• Patients must have a tumor sample available for NGS testing
• Patients are within 10 weeks of starting their current line of therapy and enrolled before their 1st computed tomography (CT) scan
• Have an expected survival of \>= 3 months, as estimated by the treating oncologist
• Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2

You may not qualify if:

• Are pregnant or nursing women
• Are unable to comply with requirements of the study
• Have a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Foundation Medicine: collaborator

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Adams EJ, Asad S, Reinbolt R, Collier KA, Abdel-Rasoul M, Gillespie S, Chen JL, Cherian MA, Noonan AM, Sardesai S, VanDeusen J, Wesolowski R, Williams N, Shapiro CL, Macrae ER, Pilarski R, Toland AE, Senter L, Ramaswamy B, Lee CN, Lustberg MB, Stover DG. Metastatic breast cancer patient perceptions of somatic tumor genomic testing. BMC Cancer. 2020 May 6;20(1):389. doi: 10.1186/s12885-020-06905-2.

  PMID: 32375690 DERIVED

Related Links

• The Jamesline

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maryam Lustberg, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 19, 2013
• Study Start: September 3, 2013
• Primary Completion: June 10, 2021
• Study Completion: June 28, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)