Patient's initial consent given for diagnostic biopsy specimen use for research on future studies (This procedure has already been performed and requires no additional procedures)
Patient's initial consent given for anal swab specimen use for research on future studies (This procedure requires putting an anal swab in the anal canal)
Beschrijving
PersonSwabCollectionConsentIndicator
Datatype
text
Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C17627
UMLS 2011AA Property
C1261188
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Patient's initial consent given for an additional diagnostic biopsy for research on future studies (This will require another biopsy to be done)
Beschrijving
PersonBiopsyConsentIndicator
Datatype
text
Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Date Informed Consent Obtained (Date informed consent obtained)
CL Item
Does The Patient Have Adequate Hematologic Function Within 14 Days Of Study Enrollment: Hemoglobin >= 10 G/dl, Platelet Count >= 100,000/mm^3, And Anc >= 1500/mm^3? (Does the patient have adequate hematologic function within 14 days of study enrollment: Hemoglobin >= 10 g/dl, Platelet count >= 100,000/mm^3, and ANC >= 1500/mm^3?)
CL Item
Does The Patient Have Adequate Hepatic Function Within 14 Days Of Study Enrollment: Ast And Alt <= 3 X Uln, And T. Bili <= 2 X Uln? (if Related To Antiretroviral Use, Then The Direct Bilirubin Must Be <= 2 X Uln.) (Does the patient have adequate hepatic function within 14 days of study enrollment: AST and ALT <= 3 X ULN, and T. Bili <= 2 X ULN? (If related to antiretroviral use, then the Direct Bilirubin must be <= 2 X ULN.))
CL Item
Does The Patient Have Creatinine <= 1.5 X The Upper Limits Of Normal (uln) Or A Creatinine Clearance Above 60 Ml/min Within 14 Days Of Study Enrollment? (Does the patient have creatinine <= 1.5 X the upper limits of normal (ULN) or a creatinine clearance above 60 mL/min within 14 days of study enrollment?)
CL Item
Does The Patient Have Documented Hiv Infection? (documentation May Be By Antibody Detection, Culture, Or Quantitative Assay Of Plasma Hiv Rna.) (Does the patient have documented HIV infection? (Documentation may be by antibody detection, culture, or quantitative assay of plasma HIV RNA.))
CL Item
Does The Patient Have Histologically Proven Stage I-iiib Invasive Anal Canal Or Perianal (anal Margin) Squamous Cell Carcinoma? (this May Include Tumors Of Non-keratinizing Histology Such As Basoloid, Transitional Cell, Or Cloacogenic Histology.) (Does the patient have histologically proven stage I-IIIB invasive anal canal or perianal (anal margin) squamous cell carcinoma? (This may include tumors of non-keratinizing histology such as basoloid, transitional cell, or cloacogenic histology.))
CL Item
Does The Patient Have The Ability And Willingness To Give Informed Consent? (Does the patient have the ability and willingness to give informed consent?)
CL Item
Has The Patient Had No Prior Chemotherapy Or No Prior Irradiation For This Malignancy? (patients With A History Of Prior Irradiation To The Planned Irradiation Field For Another Condition (eg, Kaposi's Sarcoma) May Be Eligible After Consultation.) (Has the patient had no prior chemotherapy or no prior irradiation for this malignancy? (Patients with a history of prior irradiation to the planned irradiation field for another condition (eg, Kaposi's sarcoma) may be eligible after consultation.))
CL Item
Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))
CL Item
Patient's Age (in Years) (Patient's age (in years))
Does The Patient Have A Medical Or Psychiatric Illness That Precludes Ability To Give Informed Consent Or Is Likely To Interfere With The Ability To Comply With The Protocol Stipulations? (Does the patient have a medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulations?)
CL Item
Does The Patient Have Acute, Active, Serious, Uncontrolled Opportunistic Infection? (patients With A Cd4 Count < 50/ul Will Be Excluded If They Have Had An Opportunistic Infection Within The Past 6 Months, Or If There Is Evidence Of Resistance.) (Does the patient have acute, active, serious, uncontrolled opportunistic infection? (Patients with a CD4 count < 50/uL will be excluded if they have had an opportunistic infection within the past 6 months, or if there is evidence of resistance.))
CL Item
Does The Patient Have Grade 2, 3, 4 Neuropathy? (Does the patient have Grade 2, 3, 4 neuropathy?)
CL Item
Does The Patient Have Severe (grade 3 Or 4) Or Poorly Controlled Diarrhea? (Does the patient have severe (grade 3 or 4) or poorly controlled diarrhea?)
CL Item
Has The Patient Been Diagnosed With An Invasive Malignancy Within The Past 24 Months? (excluding In Situ Cervical Cancer, Anal Dysplasia Or Carcinoma In Situ, Non-melanoma Skin Carcinoma, Kaposi's Sarcoma That Has Not Required Systemic Chemotherapy.) (Has the patient been diagnosed with an invasive malignancy within the past 24 months? (excluding in situ cervical cancer, anal dysplasia or carcinoma in situ, non-melanoma skin carcinoma, Kaposi's sarcoma that has not required systemic chemotherapy.))
CL Item
If The Patient Is A Female, Is She Pregnant Or Nursing? (If the patient is a female, is she pregnant or nursing?)
Patient's initial consent given for diagnostic biopsy specimen use for research on future studies (This procedure has already been performed and requires no additional procedures)
Patient's initial consent given for diagnostic biopsy specimen use for research on future studies (This procedure has already been performed and requires no additional procedures)
Patient's initial consent given for anal swab specimen use for research on future studies (This procedure requires putting an anal swab in the anal canal)
Patient's initial consent given for anal swab specimen use for research on future studies (This procedure requires putting an anal swab in the anal canal)
Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)