Castration Levels of Testosterone | Total Testosterone Measurement
Item
1. serum castration levels of testosterone, (total testosterone under 1.7nmol/l).
boolean
C4289828 (UMLS CUI [1])
C0202227 (UMLS CUI [2])
Raised PSA Occurrence Quantity | PSA Percent Change From Nadir
Item
2. three consecutive rises of psa minimum 1 week apart, resulting in at least two 50 % increases over the psa nadir.
boolean
C0178415 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0138741 (UMLS CUI [2,1])
C3272908 (UMLS CUI [2,2])
Androgen Antagonists Withdrawal | Raised PSA | Hormone manipulation Secondary | Bone lesion Progression | Soft tissue lesion Progression
Item
3. antiandrogen withdrawal for at least 4 weeks, or psa progression despite secondary hormonal manipulations, or progression of osseous or soft tissue lesions.
boolean
C0002842 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2])
C0586971 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0449258 (UMLS CUI [4,2])
C0410013 (UMLS CUI [5,1])
C0449258 (UMLS CUI [5,2])
Age | Informed Consent
Item
4. be over the age of 18 and capable of understanding the information and giving informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Life Expectancy
Item
5. expected survival time (life expectancy) of over 6 months.
boolean
C0023671 (UMLS CUI [1])
WHO performance status scale | ECOG performance status
Item
6. adequate performance status better than 2 (who/ecog performance status score).
boolean
C1298650 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Blood Count low | Hemoglobin measurement
Item
1. a low blood count (haemoglobin < 6.0 mmol/l).
boolean
C0005771 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
Lymphocyte Count measurement
Item
2. lymphocyte counts below 0.8 x 109/l.
boolean
C0200635 (UMLS CUI [1])
HIV-1 antibody Positive | HIV-2 antibody Positive | Hepatitis B surface antigen positive | Hepatitis B core antibody positive | Hepatitis C antibody positive
Item
3. positive tests for anti-hiv-1/2; hbsag, anti-hbc (hepatitis b core antigen) and anti-hcv (hepatitis c virus).
boolean
C0369497 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0369500 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0149709 (UMLS CUI [3])
C0262506 (UMLS CUI [4])
C0281863 (UMLS CUI [5])
Syphilis | Treponema pallidum test positive
Item
4. syphilis i.e. being positive in a treponema pallidum test.
boolean
C0039128 (UMLS CUI [1])
C2748144 (UMLS CUI [2])
Bacterial Infection Serious Uncontrolled | Virus Disease Serious Uncontrolled | Mycoses Serious Uncontrolled | Parasitic infection Serious Uncontrolled
Item
5. uncontrolled serious bacterial, viral, fungal or parasitic infection.
boolean
C0004623 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0042769 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0026946 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0747256 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
Autoimmune Diseases | Immunosuppression
Item
6. clinically significant autoimmune disorders or conditions of immune suppression.
boolean
C0004364 (UMLS CUI [1])
C4048329 (UMLS CUI [2])
Steroid therapy | Bisphosphonate therapy | Chemotherapy | Therapeutic radiology procedure
Item
7. treatment with corticosteroids (steroid hormones) or bisphosphonates or have been in chemotherapy or radiation treatment one month prior to inclusion in the clinical trial.
boolean
C0149783 (UMLS CUI [1])
C4510264 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Blood Transfusion | Status pre- Blood Donation ALECSAT
Item
8. blood transfusions within 48 hours prior to donation of blood for alecsat production.
boolean
C0005841 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C3827167 (UMLS CUI [2,3])
Study Subject Participation Status | Clinical Trial
Item
9. inclusion in other clinical trials 6 weeks prior to inclusion in the trial or enrolment in other clinical trials during the alecsat clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Medical condition Study Subject Participation Status At risk | Medical condition Assessment Side effects Difficult
Item
10. any medical condition that will render participation in the study risky or, according to the investigator will make the assessment of side effects difficult.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0879626 (UMLS CUI [2,3])
C0332218 (UMLS CUI [2,4])