Solid Tumor NeoplasmsNCT02555735
Exceptional Responders With Solid Tumor Cancer to Chemotherapy
An observational study of Solid Tumor Neoplasms, run by Adera Labs, LLC at 1 site in United States.
Trial summary
This is an observational study enrolling patients with Solid Tumor cancers to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Neoplasms
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Aug 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 diagnosed with solid tumor cancers
Who may be able to join
- Histological or cytological confirmation of solid tumor carcinoma.
- Patient is treatment-naïve or currently receiving chemotherapy.
- ECOG performance status (any).
Who cannot join
- HIV positive on antiretroviral therapy
- Pregnant or lactating
- Prior organ allograft
- Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Pancreatic Cancer Treatment Center of Los Angeles
Los Angeles, California, 90024
About this study
Official title: Evaluation of Exceptional Responders With Solid Tumor Cancer
This is an observational study enrolling patients with Solid Tumor cancers to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.
Read the detailed description
This is an observational study of patients with solid tumor cancer to identify genomic expression differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.
- Conditions
- Solid Tumor Neoplasms
- Being tested
- Standard of Care Chemotherapy
- Keywords
- Solid Tumor cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care ChemotherapyDrug
Physician's Choice Chemotherapy Treatment (non-guided)
| Study group | Role | What they receive |
|---|---|---|
| Solid Tumor Cancer | Participants with solid tumor cancer treated with physician-choice standard of care chemotherapy. Receives: Drug: Standard of Care Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify exceptional responders with cancer to standard of care chemotherapy
Identify responders and non-responders
Measured: 9 years
Secondary outcomes (1)
Correlation of genomic profiles from circulating cells with overall survival
Genomic expression profiles correlated with progression free and overall survival
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor NeoplasmsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adera Labs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Pancreatic Cancer Treatment Center of Los Angeles
- Responsible party
- Sponsor
- Investigators
- Brian McCarthy, PhD, Study director, Adera Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555735
- Sponsor's protocol ID
- ADRL-003
- Status last verified
- Jan 2023
- First submitted
- 18 Sep 2015
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu KH, Ricigliano M, McCarthy B, Chou JF, Capanu M, Cooper B, Bartlett A, Covington C, Lowery MA, O'Reilly EM. Circulating Tumor and Invasive Cell Gene Expression Profile Predicts Treatment Response and Survival in Pancreatic Adenocarcinoma. Cancers (Basel). 2018 Nov 24;10(12):467. doi: 10.3390/cancers10120467.
PubMed 30477242Isacoff WH, Cooper B, Bartlett A, McCarthy B, Yu KH. ChemoSensitivity Assay Guided Metronomic Chemotherapy Is Safe and Effective for Treating Advanced Pancreatic Cancer. Cancers (Basel). 2022 Jun 13;14(12):2906. doi: 10.3390/cancers14122906.
PubMed 35740571Yu KH, Park J, Mittal A, Abou-Alfa GK, El Dika I, Epstein AS, Ilson DH, Kelsen DP, Ku GY, Li J, Park W, Varghese AM, Chou JF, Capanu M, Cooper B, Bartlett A, McCarthy D, Sangar V, McCarthy B, O'Reilly EM. Circulating tumor and invasive cell expression profiling predicts effective therapy in pancreatic cancer. Cancer. 2022 Aug 1;128(15):2958-2966. doi: 10.1002/cncr.34269. Epub 2022 Jun 1.
PubMed 35647938
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Exceptional Responders With Solid Tumor Cancer
- ClinicalTrials.gov ID
- NCT02555735
- Acronym / sponsor ID
- ADRL-003
- Conditions
- Solid Tumor Neoplasms
- Keywords
- Solid Tumor cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Adera Labs, LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Pancreatic Cancer Treatment Center of Los Angeles
- Study start
- Oct 2015
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 Sep 2015 (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 is an observational study enrolling patients with Solid Tumor cancers to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.
Detailed description
This is an observational study of patients with solid tumor cancer to identify genomic expression differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solid Tumor Cancer | – | Drug: Standard of Care ChemotherapyParticipants with solid tumor cancer treated with physician-choice standard of care chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with solid tumor cancers
Key inclusion criteria (3 listed)
- Histological or cytological confirmation of solid tumor carcinoma.
- Patient is treatment-naïve or currently receiving chemotherapy.
- ECOG performance status (any).
Key exclusion criteria (4 listed)
- HIV positive on antiretroviral therapy
- Pregnant or lactating
- Prior organ allograft
- Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
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 |
|---|---|---|
| Standard of Care ChemotherapyPhysician's Choice Chemotherapy Treatment (non-guided) | Drug | Solid Tumor Cancer |
Primary outcome
Identify exceptional responders with cancer to standard of care chemotherapy
Time frame: 9 years
Identify responders and non-responders
1 secondary outcome
Correlation of genomic profiles from circulating cells with overall survival
Time frame: 9 years
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 1 Feb 2023.
- Background: PubMed 30477242Yu KH, Ricigliano M, McCarthy B, Chou JF, Capanu M, Cooper B, Bartlett A, Covington C, Lowery MA, O'Reilly EM. Circulating Tumor and Invasive Cell Gene Expression Profile Predicts Treatment Response and Survival in Pancreatic Adenocarcinoma. Cancers (Basel). 2018 Nov 24;10(12):467. doi: 10.3390/cancers10120467.
- Background: PubMed 35740571Isacoff WH, Cooper B, Bartlett A, McCarthy B, Yu KH. ChemoSensitivity Assay Guided Metronomic Chemotherapy Is Safe and Effective for Treating Advanced Pancreatic Cancer. Cancers (Basel). 2022 Jun 13;14(12):2906. doi: 10.3390/cancers14122906.
- Background: PubMed 35647938Yu KH, Park J, Mittal A, Abou-Alfa GK, El Dika I, Epstein AS, Ilson DH, Kelsen DP, Ku GY, Li J, Park W, Varghese AM, Chou JF, Capanu M, Cooper B, Bartlett A, McCarthy D, Sangar V, McCarthy B, O'Reilly EM. Circulating tumor and invasive cell expression profiling predicts effective therapy in pancreatic cancer. Cancer. 2022 Aug 1;128(15):2958-2966. doi: 10.1002/cncr.34269. Epub 2022 Jun 1.
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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.
Brian McCarthy, PhD study director
Adera Labs
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 Solid Tumor Neoplasms, run by Adera Labs, LLC 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 1 Feb 2023. 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?
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?
Identify exceptional responders with cancer to standard of care chemotherapy (time frame: 9 years). 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 NCT02555735, which also lists 3 linked publications.
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 1 Feb 2023.