ROS1-fusion Positive TumorNCT03497624
ALCMI-006: A Prospective Biospecimen Collection Study From Patients With ROS1-Fusion Positive Tumors
An observational study of ROS1-fusion Positive Tumor, run by Addario Lung Cancer Medical Institute at 1 site in United States.
Trial summary
Patient Derived Xenografts (PDXs) are models to study tumor growth, response to anti-cancer therapies, and resistance to anti-cancer therapies. The purpose of this study is to develop up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ROS1-fusion Positive Tumor
- What is being tested?
- Biospecimens collection
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 4 Sep 2020
- 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: Adults diagnosed with a ROS1-fusion positive cancer.
Who may be able to join
- Male or female greater than 18 years of age at the time of consent.
- Confirmed diagnosis of ROS1-fusion positive tumor via IHC, FISH and/or NGS.
- A clinically-indicated procedure (required by the patient's treating physician) scheduled no more than 30 calendar days from date of consent.
- A minimum of 21 calendar days between the last dose of systemic therapy and the clinically-indicated procedure.
- A minimum of 42 hours between the last dose of a tyrosine kinase inhibitor (TKI) and the time of the clinically-indicated procedure.
- Willingness to undergo all study collection procedures and follow up.
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- Provision of written informed consent by the patient.
- Able to communicate (read, write and speak) in English.
- Clinically-indicated procedure to be performed within the US (including Alaska, Hawaii and Puerto Rico), Canada, England, or Israel.
Who cannot join
- Less than 18 years of age at time of consent.
- No confirmed diagnosis of ROS1-fusion positive tumor via IHC, FISH and/or NGS.
- A biopsy or surgical procedure not scheduled for clinical/diagnostic purposes.
- A clinically-indicated procedure scheduled more than 30 calendar days from the date of consent.
- Receipt of systemic therapy less than 21 days from the time of the clinically-indicated procedure.
- Receipt of tyrosine kinase inhibitor less than 42 hours from the time of the clinically-indicated procedure.
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- Unwilling to undergo all study collection procedures and follow up.
- Unable or unwilling to provide consent.
- Unable to communicate in English.
- Clinically-indicated procedure not scheduled within the US, Canada, England, or Israel.
Trial locations and contacts
1 site in 1 country.
About this study
Patient Derived Xenografts (PDXs) are models to study tumor growth, response to anti-cancer therapies, and resistance to anti-cancer therapies. The purpose of this study is to develop up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only. That is, these patient derived PDX models will have no immediate benefit to the patient from whom the tumor specimen was obtained. Rather, these PDX models will be used to inform the study of ROS1-fusion driven cancers at large.
Read the detailed description
ROS1-fusions occur in several cancer types such as non-small cell lung cancer, gastric cancer, ovarian cancer, glioblastoma, cholangiocarcinoma and melanoma. In each of these cancers, ROS1-fusions account for a small sliver of the pie, accounting for 1-2% of all diagnoses, forming a relatively rare molecular subset of cancer. The Addario Lung Cancer Medical Institute (ALCMI) would like to focus on this under-studied rare molecular subset of cancer to understand how cancer begins and spreads in these tumors, how these tumors respond to treatment and what happens when tumors stop responding to treatment. Therefore, in collaboration with cancer patients whose tumors have ROS1-fusions (known as the "ROS1ders"), we are studying ROS1-fusions across all cancer types.
Patient Derived Xenografts (PDXs) are models to study cancer. These models are developed by injecting a fresh piece of tumor specimen from a patient into a special type of mouse, which then acts as 'host' to allow the tumor to grow. Peer-reviewed and published experimental studies have shown that PDX models can maintain features similar to the original tumor from the patient. PDX models can be used to study tumor growth, response to anti-cancer therapies, and resistance to anti-cancer therapies.
The purpose of this study is to develop up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only. That is, these patient derived PDX models will have no immediate benefit to the patient from whom the tumor specimen was obtained. Rather, these PDX models will be used to inform the study of ROS1-fusion driven cancers at large.
- Conditions
- ROS1-fusion Positive Tumor
- Being tested
- Biospecimens collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimens collectionOther
Collection of tumor tissue when a participant is having a clinically-indicated biopsy or surgery for their ROS1-fusion cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to develop a unique cohort of PDX models for ROS1-fusion driven cancers as a resource to the research community.
Successful generation of at least ten (10), but no more than twenty-four (24), ROS1-fusion PDX models with full characterization including whole exome sequencing (WES) and RNA sequencing. Models can be used as a resource for clinical and translational research to understand mechanisms of resistance and develop new therapies.
Measured: 1 year
Secondary outcomes (1)
The secondary/exploratory objectives are to enhance scientific knowledge of how to diagnose and treat ROS1-fusion driven cancers.
These models will be made available to researchers to enhance scientific knowledge of how to diagnose and treat ROS1-fusion driven cancers.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start23 Apr 2018
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ROS1-fusion Positive TumorStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addario Lung Cancer Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Lovly, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497624
- Sponsor's protocol ID
- ALCMI-006
- Status last verified
- Sep 2020
- First submitted
- 20 Mar 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined at a future date.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALCMI-006: A Prospective Biospecimen Collection Study From Patients With ROS1-Fusion Positive Tumors
- ClinicalTrials.gov ID
- NCT03497624
- Acronym / sponsor ID
- ALCMI-006
- Conditions
- ROS1-fusion Positive Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Addario Lung Cancer Medical InstituteUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 13 Apr 2018 (actual)
- 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.
Patient Derived Xenografts (PDXs) are models to study tumor growth, response to anti-cancer therapies, and resistance to anti-cancer therapies. The purpose of this study is to develop up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only. That is, these patient derived PDX models will have no immediate benefit to the patient from whom the tumor specimen was obtained. Rather, these PDX models will be used to inform the study of ROS1-fusion driven cancers at large.
Detailed description
ROS1-fusions occur in several cancer types such as non-small cell lung cancer, gastric cancer, ovarian cancer, glioblastoma, cholangiocarcinoma and melanoma. In each of these cancers, ROS1-fusions account for a small sliver of the pie, accounting for 1-2% of all diagnoses, forming a relatively rare molecular subset of cancer. The Addario Lung Cancer Medical Institute (ALCMI) would like to focus on this under-studied rare molecular subset of cancer to understand how cancer begins and spreads in these tumors, how these tumors respond to treatment and what happens when tumors stop responding to treatment. Therefore, in collaboration with cancer patients whose tumors have ROS1-fusions (known as the "ROS1ders"), we are studying ROS1-fusions across all cancer types.
Patient Derived Xenografts (PDXs) are models to study cancer. These models are developed by injecting a fresh piece of tumor specimen from a patient into a special type of mouse, which then acts as 'host' to allow the tumor to grow. Peer-reviewed and published experimental studies have shown that PDX models can maintain features similar to the original tumor from the patient. PDX models can be used to study tumor growth, response to anti-cancer therapies, and resistance to anti-cancer therapies.
The purpose of this study is to develop up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only. That is, these patient derived PDX models will have no immediate benefit to the patient from whom the tumor specimen was obtained. Rather, these PDX models will be used to inform the study of ROS1-fusion driven cancers at large.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with a ROS1-fusion positive cancer.
Key inclusion criteria (9 listed)
- Male or female greater than 18 years of age at the time of consent.
- Confirmed diagnosis of ROS1-fusion positive tumor via IHC, FISH and/or NGS.
- A clinically-indicated procedure (required by the patient's treating physician) scheduled no more than 30 calendar days from date of consent.
- A minimum of 21 calendar days between the last dose of systemic therapy and the clinically-indicated procedure.
- A minimum of 42 hours between the last dose of a tyrosine kinase inhibitor (TKI) and the time of the clinically-indicated procedure.
Key exclusion criteria (10 listed)
- Less than 18 years of age at time of consent.
- No confirmed diagnosis of ROS1-fusion positive tumor via IHC, FISH and/or NGS.
- A biopsy or surgical procedure not scheduled for clinical/diagnostic purposes.
- A clinically-indicated procedure scheduled more than 30 calendar days from the date of consent.
- Receipt of systemic therapy less than 21 days from the time of the clinically-indicated procedure.
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 |
|---|---|---|
| Biospecimens collectionCollection of tumor tissue when a participant is having a clinically-indicated biopsy or surgery for their ROS1-fusion cancer. | Other | – |
Primary outcome
The primary objective is to develop a unique cohort of PDX models for ROS1-fusion driven cancers as a resource to the research community.
Time frame: 1 year
Successful generation of at least ten (10), but no more than twenty-four (24), ROS1-fusion PDX models with full characterization including whole exome sequencing (WES) and RNA sequencing. Models can be used as a resource for clinical and translational research to understand mechanisms of resistance and develop new therapies.
1 secondary outcome
The secondary/exploratory objectives are to enhance scientific knowledge of how to diagnose and treat ROS1-fusion driven cancers.
Time frame: 24 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 9 Sep 2020.
- Individual participant dataSharing planned: Undecided. To be determined at a future date.
Related trials for ROS1-fusion Positive Tumor
RecruitingPhase 2
Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity
Non-Small Cell Lung Cancer
Not yet recruitingObservational study
Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion
Non-Small Cell Lung Cancer
RecruitingPhase 3
Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)
Non-small Cell Lung Cancer (NSCLC)
Enrolling by invitationObservational study
Integrated Genomics in Oncogene-driven NSCLC With Acquired Resistance
Oncogene-addicted Non Small Cell Lung Cancer, EGFR Mutation
Active, not recruitingPhase 2
A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene
Non Small Cell Lung Cancer
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.
Christine Lovly, MD, PhD principal investigator
Vanderbilt University Medical 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 ROS1-fusion Positive Tumor, run by Addario Lung Cancer Medical Institute 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 9 inclusion and 10 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 9 Sep 2020. 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?
The primary objective is to develop a unique cohort of PDX models for ROS1-fusion driven cancers as a resource to the research community. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.