Malignant NeoplasmNCT02243592
Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
An observational study of Malignant Neoplasm, run by National Cancer Institute (NCI) at 73 sites in United States.
Trial summary
This pilot research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 170 participants
- Where
- 73 sitesUnited States
- Study dates
- 24 Sep 2014to 30 Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer participating in the Exceptional Cases Initiative
Who may be able to join
- Documented exceptional response, defined as patients meeting the following criteria:
- Complete response to a regimen in which complete response is expected in < 10% of similarly treated patients
- Partial response (PR) > 6 months in a regimen in which PRs > 6 months are expected in < 10% of patients with similar disease treated with same or similar regimen
- Complete response (CR) or PR of unusual duration, such that the internal review committee considers it to be an exceptional response; examples below:
- PR of duration > 3 x the median expected PR duration (in cases where PR is expected in > 10% of patients with the same disease treated with the same regimen)
- CR or duration > 3 x the median expected CR duration (in cases where CR may be seen in > 10% of patients with same disease treated with same regimen)
Show all 17Show fewer
- The observed duration of CR (or PR) is longer than expected for 90% of patients with same disease treated with same regimen
- Note: it is not required that the patient be enrolled on a clinical trial when the exceptional response was observed
- Reports of radiologic scans or other evidence documenting response will be submitted for review; cases where response is not assessable (e.g. adjuvant treatment) will not be eligible because the outcome can not be attributed to a specific treatment
- Treatment history must be available, for prior treatment and for the drug to which the exceptional response occurred
- Patient must meet consent criteria; this requires: (i) current exceptional responder (ER) consent by a living participant not lost to follow-up, (ii) prior consent for future research by a participant not known to be deceased, but lost to follow-up, or (iii) if patient is deceased and did not decline to participate in research at the time of tissue removal for any tissue that would be used in this study, then no consent is required
- Tumor sample available that meets study requirements
- Required tumor samples MUST exist and be able to be submitted; investigators wishing to submit samples must not have made agreements that would prohibit the free use of data from such samples; the National Cancer Institute (NCI) will provide investigators with a letter for the collaborator amending their existing agreement to allow for the case to be submitted
- Tumor tissue from prior to administration of the drug to which the exceptional response occurred is required; ideally this sample will have been collected just prior to treatment, but other prior tissue will be considered; tissue may be fresh frozen or formalin-fixed paraffin embedded
- Tumor tissue amount must be at least a core biopsy, and meet minimum specimen requirements
- Encouraged: normal tissue sample: (optional): blood or other specimen source for germline sequencing
- The tumor samples and clinical data submitted to the Exceptional Responders Database in database in Genotypes and Phenotypes (dbGaP) will need to have appropriate agreements in place to allow for the submission; the Exceptional Responders Database can accept clinical data and samples from cases enrolled on a Cancer Therapy Evaluation Program (CTEP) sponsored clinical trial and cases that were not enrolled on any clinical trial; if the response occurred on a trial that was not CTEP-sponsored, there are existing agreements between the submitting site and the pharmaceutical company; if existing agreements do not allow for the submission of sample and clinical data, the NCI will provide the investigators with a letter that allows the tissue to be used for the exceptional responders study if signed by the appropriate collaborator; the letter modifies the existing agreement to include the CTEP Intellectual Property (IP) Option language that would allow the case to be submitted to the Exceptional Responders Database; if the existing agreement cannot be modified and the letter cannot be signed, the proposed case will not be accepted; Note: as stated above, the patient does not need to have been enrolled on a clinical trial to be eligible for the exceptional responders study
Who cannot join
- Patient's response did not meet criteria for an exceptional response
- Patient's treatment regimen is expected to lead to CR or durable PR in > 10% of patients
- Patient's duration of response is not > 3 x expected median length of response
- Response not evaluable or not able to be attributed to systemic treatment (e.g. adjuvant treatment)
- Patient refused consent for use of tissue for research activities included in the exceptional responders study
- Tumor sample from prior to the exceptional response is not available, or does not meet quality metrics
Trial locations and contacts
73 sites in 1 country.
73 sites in 1 country
United States73 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, 20892
NCI - Center for Cancer Research
Bethesda, Maryland, 20892
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
Presence Resurrection Medical Center
Chicago, Illinois, 60631
John B Amos Cancer Center
Columbus, Georgia, 31904
Riverside Methodist Hospital
Columbus, Ohio, 43214
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Kaiser Permanente-Fresno
Fresno, California, 93720
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Greenwich Hospital
Greenwich, Connecticut, 06830
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Ben Taub General Hospital
Houston, Texas, 77030
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
UP Health System Hematology Oncology Marquette
Marquette, Michigan, 49855
UP Health System Marquette
Marquette, Michigan, 49855
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Kaiser Permanente-Oakland
Oakland, California, 94611
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Reading Hospital McGlinn Cancer Institute at Phoenixville
Phoenixville, Pennsylvania, 19460
Kaiser Permanente Northwest
Portland, Oregon, 97227
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03802
Kaiser Permanente-Richmond
Richmond, California, 94801
University of Rochester
Rochester, New York, 14642
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075
Springfield Clinic
Springfield, Illinois, 62702
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Washington University School of Medicine
St Louis, Missouri, 63110
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Kaiser Permanente-Stockton
Stockton, California, 95210
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, 31602
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Chester County Hospital
West Chester, Pennsylvania, 19380
Reading Hospital
West Reading, Pennsylvania, 19611
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
York Hospital
York Village, Maine, 03909
About this study
Official title: Exceptional Responders Pilot Study: Molecular Profiling of Tumors From Cancer Patients Who Are Exceptional Responders
This pilot research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to how well patients respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To identify molecular indicators in malignant tissues from patients who were exceptional responders on clinical trials or standard systemic treatments using whole exome and/or targeted deep sequencing, as well as potentially other sequencing and other molecular characterization methods (if adequate tissue exists).
II. To explore associations between the identified molecular indicators and the putative mechanism of action of the treatment received by the patient.
III. To test the feasibility of identifying "exceptional responders", obtaining the relevant tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep sequencing on these samples.
OUTLINE:
Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted next generation sequencing (NGS) assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, messenger ribonucleic acid (RNA) (mRNA)-sequencing, micro (miRNA) sequencing, promoter methylation analysis, and single nucleotide polymorphism (SNP) analysis.
- Conditions
- Malignant Neoplasm
- Being tested
- 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.
Laboratory Biomarker AnalysisOther
Undergo sequencing and SNP analysis
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (molecular profiling) | Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted NGS assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, mRNA-sequencing, miRNA sequencing, promoter methylation analysis, and SNP analysis. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular features in tissue samples from patients who were exceptional responders
The molecular features of the tumors in the patients will be discernible as distinct to the tumor by comparison to (i) samples from normal tissue in the same patient and (ii) databases of similar data for normal and other tumor types.
Measured: Baseline
Putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses
The associations between identified molecular features and the putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses will be explored. Statistical analyses will be primarily descriptive.
Measured: Baseline
Number of cases identified as potential exceptional responders
Statistical analyses will be primarily descriptive.
Measured: Baseline
Percentage of identified potential cases confirmed to be exceptional responders
Statistical analyses will be primarily descriptive.
Measured: Baseline
Percentage of confirmed exceptional responders for which adequate tissue with appropriate informed consent is acquired
Statistical analyses will be primarily descriptive.
Measured: Baseline
Percentage of acquired cases with tissue for which at least the minimum molecular characterization is successfully obtained
Statistical analyses will be primarily descriptive.
Measured: Baseline
Percentage of molecularly characterized cases for which a Molecular Characterization report identified (without reference to the drug received by the patient) at least one feature judged to have potential therapeutic relevance
Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by an expert panel ("Panel") to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Measured: Baseline
Percentage of cases with >= 1 feature on Molecular Characterization report that was judged to have potential therapeutic relevance to the specific class of drug the patient actually received when the exceptional response was experienced
Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Measured: Baseline
Percentage of cases with >= 1 feature that correlates with the mechanism of action of the specific grant to which the exceptional response occurred that was found after further analyzing the molecular profile data for relevant molecular abnormalities
Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study start24 Sep 2014
- Primary completion4 Mar 2021
- Study completion30 Apr 2027 (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 National Cancer Institute (NCI)The 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-control
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- S. P Ivy, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243592
- Sponsor's protocol ID
- NCI-2014-01585
- Other IDs
- NCI-2014-01585, 9671, 9671, UM1CA186704
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2014
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moore KN, Mannel RS. Is the NCI MATCH trial a match for gynecologic oncology? Gynecol Oncol. 2016 Jan;140(1):161-6. doi: 10.1016/j.ygyno.2015.11.003. Epub 2015 Nov 14.
PubMed 26586415
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exceptional Responders Pilot Study: Molecular Profiling of Tumors From Cancer Patients Who Are Exceptional Responders
- ClinicalTrials.gov ID
- NCT02243592
- Acronym / sponsor ID
- NCI-2014-01585
- Conditions
- Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 24 Sep 2014 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Sep 2014 (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 research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to how well patients respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- To identify molecular indicators in malignant tissues from patients who were exceptional responders on clinical trials or standard systemic treatments using whole exome and/or targeted deep sequencing, as well as potentially other sequencing and other molecular characterization methods (if adequate tissue exists).
II. To explore associations between the identified molecular indicators and the putative mechanism of action of the treatment received by the patient.
III. To test the feasibility of identifying "exceptional responders", obtaining the relevant tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep sequencing on these samples.
OUTLINE:
Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted next generation sequencing (NGS) assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, messenger ribonucleic acid (RNA) (mRNA)-sequencing, micro (miRNA) sequencing, promoter methylation analysis, and single nucleotide polymorphism (SNP) analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (molecular profiling) | – | Other: Laboratory Biomarker AnalysisPreviously collected tissue samples are analyzed via whole exome sequencing and/or targeted NGS assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, mRNA-sequencing, miRNA sequencing, promoter methylation analysis, and SNP analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer participating in the Exceptional Cases Initiative
Key inclusion criteria (17 listed)
- Documented exceptional response, defined as patients meeting the following criteria:
- Reports of radiologic scans or other evidence documenting response will be submitted for review; cases where response is not assessable (e.g. adjuvant treatment) will not be eligible because the outcome can not be attributed to a specific treatment
- Treatment history must be available, for prior treatment and for the drug to which the exceptional response occurred
- Patient must meet consent criteria; this requires: (i) current exceptional responder (ER) consent by a living participant not lost to follow-up, (ii) prior consent for future research by a participant not known to be deceased, but lost to follow-up, or (iii) if patient is deceased and did not decline to participate in research at the time of tissue removal for any tissue that would be used in this study, then no consent is required
- Tumor sample available that meets study requirements
Key exclusion criteria (6 listed)
- Patient's response did not meet criteria for an exceptional response
- Patient's treatment regimen is expected to lead to CR or durable PR in > 10% of patients
- Patient's duration of response is not > 3 x expected median length of response
- Response not evaluable or not able to be attributed to systemic treatment (e.g. adjuvant treatment)
- Patient refused consent for use of tissue for research activities included in the exceptional responders study
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 |
|---|---|---|
| Laboratory Biomarker AnalysisUndergo sequencing and SNP analysis | Other | Ancillary-Correlative (molecular profiling) |
Primary outcome
Molecular features in tissue samples from patients who were exceptional responders
Time frame: Baseline
The molecular features of the tumors in the patients will be discernible as distinct to the tumor by comparison to (i) samples from normal tissue in the same patient and (ii) databases of similar data for normal and other tumor types.
Putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses
Time frame: Baseline
The associations between identified molecular features and the putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses will be explored. Statistical analyses will be primarily descriptive.
Number of cases identified as potential exceptional responders
Time frame: Baseline
Statistical analyses will be primarily descriptive.
Percentage of identified potential cases confirmed to be exceptional responders
Time frame: Baseline
Statistical analyses will be primarily descriptive.
Percentage of confirmed exceptional responders for which adequate tissue with appropriate informed consent is acquired
Time frame: Baseline
Statistical analyses will be primarily descriptive.
Percentage of acquired cases with tissue for which at least the minimum molecular characterization is successfully obtained
Time frame: Baseline
Statistical analyses will be primarily descriptive.
Percentage of molecularly characterized cases for which a Molecular Characterization report identified (without reference to the drug received by the patient) at least one feature judged to have potential therapeutic relevance
Time frame: Baseline
Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by an expert panel ("Panel") to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Percentage of cases with >= 1 feature on Molecular Characterization report that was judged to have potential therapeutic relevance to the specific class of drug the patient actually received when the exceptional response was experienced
Time frame: Baseline
Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Percentage of cases with >= 1 feature that correlates with the mechanism of action of the specific grant to which the exceptional response occurred that was found after further analyzing the molecular profile data for relevant molecular abnormalities
Time frame: Baseline
Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
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 30 Sep 2026.
- Derived from this study: PubMed 26586415Moore KN, Mannel RS. Is the NCI MATCH trial a match for gynecologic oncology? Gynecol Oncol. 2016 Jan;140(1):161-6. doi: 10.1016/j.ygyno.2015.11.003. Epub 2015 Nov 14.
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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.
S. P Ivy principal investigator
National Cancer Institute (NCI)
73 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 National Cancer Institute (NCI) at 73 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 17 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 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?
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?
Molecular features in tissue samples from patients who were exceptional responders (time frame: Baseline). The study lists 9 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 NCT02243592, 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 30 Sep 2026.