ALCMI-006: A Prospective Biospecimen Collection Study From Patients With ROS1-Fusion Positive Tumors

Completed

Conditions studied: ROS1-fusion Positive Tumor

In brief

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.

Key facts

Study ID

NCT03497624

Run by

Addario Lung Cancer Medical Institute

People needed

5

Starts

2018-04-23

Expected to finish

2020-09-04

Last updated by the study team

2020-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• ALCMI — San Carlos, California, United States

Full record on ClinicalTrials.gov

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