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I-Corps for SBIR Phase I: Giant Macrophage-like Cells as a blood-based Biomarker for Lung Cancer Recurrence

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA206840-01A1
Agency Tracking Number: R43CA206840
Amount: $305,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA19-029
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-06-20
Award End Date (Contract End Date): 2019-05-31
Small Business Information
Potomac, MD 20854-1221
United States
DUNS: 008723694
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (301) 983-1650
Business Contact
Phone: (301) 983-1650
Research Institution

ABSTRACT Lung cancer is the leading cause of death in the United States and worldwideInan estimatedadults will be diagnosed with lung cancer andwill die from the disease in the United StatesThe rate of recurrence after initial treatment ranges betweentodepending on the stage at initial diagnosisThe death rate is very high within one year after recurrenceapproximatelytodepending on stageIt is generally acknowledged that earlier detection of recurrence before it is detectable by imaging may help improve the effectiveness of salvage therapyThe goal of this Phase I SBIR is to evaluate a non invasive biomarker in the blood of cancer patients for early detection of lung cancer recurrenceThe standard of care to monitor for recurrence is CTor PET CT imagingThere are two drawbacks to imaginglack of specificitywhich may not accurately identify tumor recurrencefor exampleinflammation mimics tumor regrowthandinsufficient sensitivityrequiring tumors to be large enough for visual identificationTypicallytumors must show growth over serial imaging analyses and be larger thanmm to become suspiciousWe propose that the newly characterized cancer associate macrophage like cellCAMLwhich is found circulating in the blood of patients with cancermay be a candidate for aiding earlier detection of lung cancer recurrencePreliminary clinical data has shown that CAMLs are found in andgtof stage Iand andgtof stages II IVin numerous cancer typesbreastprostatelung and pancreatic cancersbut not found in people without cancerCAMLs have been shown to be more sensitive in detecting cancer than circulating tumor cellsor circulating tumor DNAand are specifically present in progressing malignanciesIn this Phase I SBIRblood will be collected fromstage II and III unresectable patients treated by chemoradiation at three time intervalsat last treatment and at the time of imagingmonths andmonths after treatmentThe specific aims are to show that the presence of CAMLs is correlative with early recurrence in lung cancer and further that CAMLs can detect disease recurrence earlier than standard surveillance imaging methods Narrative Lung cancer is the leading cause of death in the United StatesThe disease frequently recurs after initial treatmentand death rate is overwithin a year after the recurrenceA simple blood test has the potential to provide early detection of cancer recurrenceproviding opportunity for more effective treatment and longer survival

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