Recurrent Breast CancerNCT01987726
Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
An observational study of Recurrent Breast Cancer and Recurrent Colon Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Rectal Cancer
- What is being tested?
- cytology specimen collection procedure and laboratory biomarker analysis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2013to 28 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with recurrent or metastatic a solid tumor cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Decision Impact Analysis of Foundation Medicine's Next Generation Sequencing Test in Advanced Solid Tumor Malignancies
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and logistics associated with a clinical trial utilizing the Foundation Medicine Incorporated (FMI) test in an academic therapeutic setting.
II. To determine the proportion of patients who will receive a cancer-related therapy based on the results provided by the FMI test.
SECONDARY OBJECTIVES:
- To explore and report estimates of progression free survival (PFS) of the regimen administered after the FMI test results are revealed and the PFS of the most recent regimen administered before the FMI test results were received.
II. To determine the feasibility of performing Next Generation Sequencing (NGS) on metastatic tumor tissue.
III. To determine the feasibility of administering cancer-related drugs that are proposed by the results of NGS that are not Food and Drug Administration (FDA)-approved for a patient's specific cancer diagnosis.
IV. To collect and report the molecular alterations discovered by NGS of advanced breast and colorectal cancer.
- To determine in an exploratory manner the concordance of the genomic alterations detected by the FMI test in circulating tumor cells (CTCs) to the genomic alterations detected by FMI test in tumor tissues collected from the same patient.
OUTLINE:
PART I: Within 10 weeks of beginning a treatment regimen, tumor tissue samples and CTCs 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.
After completion of study, patients are followed up for at least 18 months.
- Conditions
- Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Breast Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer
- Being tested
- cytology specimen collection procedure, laboratory biomarker analysis
- Keywords
- Solid Tumor Malignancies
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytology specimen collection procedureOther
Also called cytologic sampling
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.
laboratory biomarker analysisOther
Also called Correlative studies, blood samples
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: cytology specimen collection procedure; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 18 months
Availability of recommended experimental regimens via clinical trials
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study start3 Sep 2013
- Primary completion10 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Medicine
- Responsible party
- Sponsor
- Investigators
- Maryam Lustberg, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987726
- Sponsor's protocol ID
- OSU-12067
- Other IDs
- NCI-2013-00872
- Status last verified
- Oct 2021
- First submitted
- 13 Nov 2013
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32375690
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Impact Analysis of Foundation Medicine's Next Generation Sequencing Test in Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT01987726
- Acronym / sponsor ID
- OSU-12067
- Conditions
- Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Breast Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer
- Keywords
- Solid Tumor Malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Foundation Medicine
- Study start
- 3 Sep 2013 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and logistics associated with a clinical trial utilizing the Foundation Medicine Incorporated (FMI) test in an academic therapeutic setting.
II. To determine the proportion of patients who will receive a cancer-related therapy based on the results provided by the FMI test.
SECONDARY OBJECTIVES:
- To explore and report estimates of progression free survival (PFS) of the regimen administered after the FMI test results are revealed and the PFS of the most recent regimen administered before the FMI test results were received.
II. To determine the feasibility of performing Next Generation Sequencing (NGS) on metastatic tumor tissue.
III. To determine the feasibility of administering cancer-related drugs that are proposed by the results of NGS that are not Food and Drug Administration (FDA)-approved for a patient's specific cancer diagnosis.
IV. To collect and report the molecular alterations discovered by NGS of advanced breast and colorectal cancer.
- To determine in an exploratory manner the concordance of the genomic alterations detected by the FMI test in circulating tumor cells (CTCs) to the genomic alterations detected by FMI test in tumor tissues collected from the same patient.
OUTLINE:
PART I: Within 10 weeks of beginning a treatment regimen, tumor tissue samples and CTCs 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.
After completion of study, patients are followed up for at least 18 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (NGS, FMI testing) | – | Other: cytology specimen collection procedure, Other: laboratory biomarker analysisPART 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with recurrent or metastatic a solid tumor cancer.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytology specimen collection procedureAlso: cytologic samplingUndergo 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. | Other | Observational (NGS, FMI testing) |
| laboratory biomarker analysisAlso: Correlative studies, blood samples2 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. | Other | Observational (NGS, FMI testing) |
Primary outcome
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
Time frame: Up to 18 months
Summary tables will be generated.
Feasibility of NGS result-based non-FDA-approved treatment plan, measured by reasons for ability or inability to receive an anti-cancer agent
Time frame: Up to 18 months
Summary tables will be generated.
Availability of recommended experimental regimens via clinical trials
Time frame: Up to 18 months
Proportion of patients who have one recommended therapy
Time frame: Up to 18 months
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.
Proportion of patients who have multiple options recommended
Time frame: Up to 18 months
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.
1 secondary outcome
Presence of any oncogene or tumor suppressor gene mutations or amplifications identified by NGS on tumor tissue in each cohort
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Derived from this study: PubMed 32375690Adams 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.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Lustberg, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Breast Cancer and Recurrent Colon Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01987726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.