Multicenter International Cross-Sectional Evaluation of Pulmonary Alveolar Proteinosis (MICEPAP) Trial

dbGaP Study Accession: phs001309.v1.p1

Subject Sample Telemetry Report (SSTR)

Study version history

Study
phs001309.v1.p1

Document Name and Accession

Document Name: RLD 5706 Forms (Jun 2008)
Document Accession: phd007621.1

Document

View pdf copy of original document

RLD 5706 Forms (Jun 2008)

Version Date: 23Jun08

RDCRN Protocol #5706 RLDC MICEPAP Study

Local ID

Participant ID

1. Clinical Site, Person Completing this Form, and Date of Data Entry

Clinical Site ID:

Name of person completing form:

Signature:

Date this form was completed: (dd/mm/yyyy)

Initial data entry completed using:

Paper case report formOnline data entry form

2. Participant

Local participant ID number:

RDCRN participant ID number:

3. Key Dates

Date symptoms started: (dd/mm/yyyy)

Date of first visit to a doctor about this problem: (dd/mm/yyyy)

Date a definitive diagnosis of PAP was made: (dd/mm/yyyy)

Date of first treatment for PAP: (dd/mm/yyyy)

Date serum was collected for this study: (dd/mm/yyyy)

Date serum shipped for evaluation in this study: (dd/mm/yyyy)

4. Demographics

Date of birth: (dd/mm/yyyy)

Place of birth:

Country:

State:

Provence:

Prefecture:

Current Residence:

Country:

State:

Provence:

Prefecture:

Gender:

MaleFemaleUnknown or not Reported

Ethnicity (select one):

Hispanic or LatinoNot Hispanic or LatinoUnknown

5. Clinical Presentation

Was any other treatment initiated before PAP was diagnosed?

YesNoUnknown

If yes, describe treatment:

6. Diagnosis

At the time of diagnosis of PAP, was serum GM-CSF autoantibody measured?

YesNoUnknown

Result: (μg/ml) (titer (for serial dilution method))

Was the GM-CSF autoantibody titer used to determine the diagnosis?

YesNoUnknown

7. Tobacco Exposure

Unknown

Never smoker:

YesNo

Current smoker:

YesNo

Ex-smoker:

YesNo

If ex-smoker, when did smoking stop: (dd/mm/yyyy)

If current or ex-smoker, indicated smoking type:

CigarettesCigarsPipe

Duration of smoking: (number of years)

Amount of smoking: (number of packs per day)

Comments:

8. Occupational Exposure

Occupation(s):

Describe exposure, include intensity & timing & duration (years):

9. Medical Illnesses

Other Medical Illnesses:

10. Infection

Has any serious infection been identified since the time of diagnosis?

YesNoUnknown

Other location (describe / comments):

Comments:

11. Medical Illnesses in Family Members

Do any of the participant’s family members have the following:

PAP

YesNoUnknown

Relationship of affected person*:

If yes, what clinical form of PAP:

Autoimmune disease

YesNoUnknown

Relationship of affected person*:

If yes, what autoimmune disease:

Other disease(s)

YesNoUnknown

Relationship of affected person*:

If yes, what other disease:

*Relationship examples:
(Mother, Father, Maternal Grandmother, Maternal Grandfather, Paternal Grandmother, Paternal Grandfather, Daughter, Son, Sister, Brother, Maternal Aunt, Maternal Uncle, Paternal Aunt, Paternal Uncle, Other Biological Relative)

12. Treatment

13. Serum collection

Initials: