Malignant NeoplasmNCT02688517
Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer
An observational study of Malignant Neoplasm, run by Rutgers, The State University of New Jersey at 11 sites in United States.
Trial summary
This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis
- How many people
- 1,100 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2013to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Persons with Cancer
Who may be able to join
- Karnofsky/Lansky performance score >= 30
- A signed written informed consent
- Evaluation in surgical/medical/radiation oncology/radiology clinic, with a history of biopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis with standard therapy; priority will be given to rare cancers with poor prognosis and lack of effective standard therapy; study principal investigator (PI) or designee will review and approve each case before enrollment
- Paraffin blocks of the patient's tumor tissue are available and accessible for analysis
Who cannot join
- Karnofsky/Lansky performance score < 30
- Life expectancy < 3 months
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trials Office contact
11 sites in 1 country
United States11 sites, 2 recruiting
- Completed
Ocean Medical Center
Brick, New Jersey, 08724
- Completed
Bayshore Community Hospital
Holmdel, New Jersey, 07733
- Recruiting
RWJBarnabas Health - Jersey City Medical Center, Jersey City
Jersey City, New Jersey, 07302
Gregory Riedlinger
- Withdrawn
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
- Completed
Southern Ocean County Medical Center
Manahawkin, New Jersey, 08050
- Completed
Morristown Medical Center
Morristown, New Jersey, 07960
- Completed
Jersey Shore Medical Center
Neptune City, New Jersey, 07753
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Clinical Trials Office, 732-235-8675
Gregory Riedlinger
- Completed
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, 07701
- Active, not recruiting
Riverview Medical Center
Red Bank, New Jersey, 07701
- Completed
Overlook Hospital
Summit, New Jersey, 07902
About this study
Official title: Targeted Genomic Analysis of Human Cancers
This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies.
II. To collect clinical outcomes of patients with actionable mutations for which sequencing has been performed.
III. To obtain tumor genome data for data storage and future computational analysis and correlation with clinical data.
IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models.
OUTLINE:
Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free deoxyribonucleic acid (DNA) and circulating tumor cells.
After completion of study, patients are followed up every 3 months for 2 years and then every 6 months for 15 years.
- Conditions
- Malignant Neoplasm
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
- Medical subject headings
- 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 blood samples
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (genomic analysis) | Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free DNA and circulating tumor cells. 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.
Frequencies of individual specific mutations and combinations of mutations of related pathway genes
Descriptive analysis will be used to determine frequencies of specific mutations and to determine the pathways that can be targeted most frequently in patients with rare/poor prognosis cancer.
Measured: Up to 15 years
Rate of actionable mutations in rare and/or poor prognosis cancers
The actual rate of mutations found in this study will be determined to estimate the true underlying mutation rate.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startFeb 2013
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
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 Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Frances Di Clemente, Rutgers, The State University of New Jersey
- Investigators
- Shridar Ganesan, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688517
- Sponsor's protocol ID
- Pro2012002075
- Other IDs
- NCI-2015-01812, CINJ # 001209, 001209, P30CA072720, Pro2012002075
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2016
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Blaszczyk MB, Boukhar SA, Zhou Z, Berim L, Ganesan S, Riedlinger GM. Occult collision tumor of the gastroesophageal junction comprising adenocarcinomas with distinct molecular profiles. Cancer Genet. 2025 Apr;292-293:27-34. doi: 10.1016/j.cancergen.2025.01.001. Epub 2025 Jan 4.
PubMed 39805155
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Genomic Analysis of Human Cancers
- ClinicalTrials.gov ID
- NCT02688517
- Acronym / sponsor ID
- Pro2012002075
- Conditions
- Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- Feb 2013
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 23 Feb 2016 (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 research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.
Detailed description
PRIMARY OBJECTIVES:
- To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies.
II. To collect clinical outcomes of patients with actionable mutations for which sequencing has been performed.
III. To obtain tumor genome data for data storage and future computational analysis and correlation with clinical data.
IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models.
OUTLINE:
Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free deoxyribonucleic acid (DNA) and circulating tumor cells.
After completion of study, patients are followed up every 3 months for 2 years and then every 6 months for 15 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (genomic analysis) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisPreviously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free DNA and circulating tumor cells. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons with Cancer
Key inclusion criteria (4 listed)
- Karnofsky/Lansky performance score >= 30
- A signed written informed consent
- Evaluation in surgical/medical/radiation oncology/radiology clinic, with a history of biopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis with standard therapy; priority will be given to rare cancers with poor prognosis and lack of effective standard therapy; study principal investigator (PI) or designee will review and approve each case before enrollment
- Paraffin blocks of the patient's tumor tissue are available and accessible for analysis
Key exclusion criteria (2 listed)
- Karnofsky/Lansky performance score < 30
- Life expectancy < 3 months
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 blood samples | Other | Ancillary-Correlative (genomic analysis) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (genomic analysis) |
Primary outcome
Frequencies of individual specific mutations and combinations of mutations of related pathway genes
Time frame: Up to 15 years
Descriptive analysis will be used to determine frequencies of specific mutations and to determine the pathways that can be targeted most frequently in patients with rare/poor prognosis cancer.
Rate of actionable mutations in rare and/or poor prognosis cancers
Time frame: Up to 15 years
The actual rate of mutations found in this study will be determined to estimate the true underlying mutation rate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 39805155Blaszczyk MB, Boukhar SA, Zhou Z, Berim L, Ganesan S, Riedlinger GM. Occult collision tumor of the gastroesophageal junction comprising adenocarcinomas with distinct molecular profiles. Cancer Genet. 2025 Apr;292-293:27-34. doi: 10.1016/j.cancergen.2025.01.001. Epub 2025 Jan 4.
- 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.
Clinical Trials Office contact
Shridar Ganesan principal investigator
Rutgers Cancer Institute of New Jersey
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm, run by Rutgers, The State University of New Jersey at 11 sites 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Office (732-235-2465), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of individual specific mutations and combinations of mutations of related pathway genes (time frame: Up to 15 years). The study lists 2 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 NCT02688517, 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 17 Apr 2026.