Specicare is seeking collaborative relationships with pulmonary medicine groups across the USA that have access to high-risk smoking populations for a research study that involves patient identification and a simple one time blood draw. Specicare handles all back office functions so this trial requires limited onsite research capabilities, as outlined below. This study is designed to confirm the validity of a lung cancer early detection test. Your organization will be well compensated for your work. The patient also receives a reasonable stipend for participation. Protocol is available for review once we have worked out our relationship.
Specicare anticipates that this will be the first of at least two studies of this type so this is not a one off.
We also seek a relationship centered around our capabilities as a cryopreservation biobank for your patients. We are able to cryopreserve the tissue and/or blood of your patients without charge for the collection and cryopreservation storage for the first six months. While this is a separate topic of discussion, we do offer these services as well as ex-vivo drug panel testing for your consideration, as well.
We anticipate that this specific lung cancer screening study will last a minimum of 18 months and can take place within the normal flow of daily clinical care.
There are 3 cohorts in this study.
Cohort 1. Already diagnosed lung cancer but not treated. These must be asymptomatic patients either found through screening or found incidentally on studies for other purposes. These patients may not have “red flag” symptoms of lung cancer, such as progressive cough, weight loss, etc. We suggest these patients are signed up the day they come back in to learn of their diagnosis, but Specicare and your practice lead will work through best practices in your specific location(s). Blood must be collected prior to initiation of treatment.
Cohort 2. Suspected cases. Patients with suspicion of lung cancer based on LDCT or CT or PET, who are coming in for biopsies in the next 60 days. Prior to the biopsy or, preferably, the day of the biopsy. We anticipate perhaps 20 to 30 % of these patients will end up having lung cancer, thus contributing to the study findings.
Cohort 3. Patients who have had LDCTs within the past 13 months in which the LRADs scores do not require biopsy. These are our controls.
Exclusionary Criteria
Limited smoking history.
Bone marrow or organ transplant.
Transfusion in past month.
Active cancer of other types or ongoing treatment for cancer of any type.
Inclusionary Criteria
20 pack year smokers aged 50 to 80
As above.
Responsibilities and compensation for successfully enrolled, completed, and accepted patients
Patient identification and onboarding (discussion of trial and coordination of trial performance with clinical care activities): $125.00
Patient consent and filling out questionnaire: $100 (If selected to be done by your practice)
EMR coordination with Specicare: $50
Blood drawing, document completion, and kit shipping: $50 and $50
Coordination of trial by Sub investigator with Principal Investigator of Specicare (Ken Dixon, MD) $25
Human resources needed to participate:
Physician, FNP, or PA as local SubInvestigator with responsibility over local site performance and interaction at outset and as needed with PI of Specicare
Nurse or NA or clinical trials person (Back up as needed)
This may not be done by committee due to the need to be on delegation log and need to follow detailed study instructions.
Requirements of local personnel
Sign delegation log as to activities permitted on this study
Training module accomplished at outset.
Interact with Specicare team on an active basis to avoid errors.
No pathology slides are needed for this study.
Contact us today for more information or to enroll in this exciting clinical trial. (833) 242-2873
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