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Comment: For CTRPMICRO-487: Revised based on the JIRA description.

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Advanced Tables - Table Plus

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Data Fields Sample TSR Data Sample Corresponding XML Data Comments

Record Verification Date 2013-03 <verification_date>2013-03</verification_date> NA

Trial Category

Complete

(Not included in the XML file)

ClinicalTrials.gov does not capture this field

Trial Type

Interventional

<study_type>Interventional</study_type>

NCI Trial Identifier

NCI-2011-9999

<id_info>
<secondary_id>
<id>NCI-2011-99999</id>
<id_type>Registry Identifier</id_type>
<id_domain>CTRP (Clinical Trial Reporting Program)</id_domain>
</secondary_id>
</id_info>

ClinicalTrials.gov Identifier

NCT01234567

(Not included in the XML file)

Lead Organization (Trial) Identifier

CCCCWFU 12345

<org_study_id>CCCCWFU 12345</org_study_id>

and

<id_info>
<secondary_id>
<id>CCCCWFU 12345</id>
<id_type>Other Identifier</id_type>
<id_domain>Wake Forest University Health Sciences</id_domain>
</secondary_id>
</id_info>

Wake Forest University Health Sciences is the Lead Organization in this example

DCP Identifier

WFU-01-01-06

<id_info>
<secondary_id>
<id>WFU-01-01-06</id>
<id_type>Registry Identifier</id_type>
<id_domain>DCP</id_domain>
</secondary_id>
</id_info>

ClinicalTrials.gov captures all other identifiers as <secondary_id>

CTEP Identifier

WFU-01-01-06

<id_info>
<secondary_id>
<id>WFU-01-01-06</id>
<id_type>Registry Identifier</id_type>
<id_domain>CTEP</id_domain>
</secondary_id>
</id_info>

ClinicalTrials.gov captures all other identifiers as <secondary_id>

CCR Identifier

CCR-123

(Not included in the XML file)

ClinicalTrials.gov captures all other identifiers as <secondary_id>

Amendment Date 02/10/2003 (Not included in the XML file) ClinicalTrials.gov does not capture this field

Amendment Number 35 (Not included in the XML file) ClinicalTrials.gov does not capture this field

Type

Interventional

<study_type>Interventional</study_type>

Official Title

A Phase II Double-Blind Feasibility Study of Armodafinil...

<official_title>
A Phase II Double-Blind Feasibility Study of Armodafinil...
</official_title>

Brief Title

Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors

<brief_title>
Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors
</brief_title>

Acronym ABC <acronym> NA

Brief Summary

This clinical trial is studying how well Armodafinil works...

<brief_summary>
<textblock>
This clinical trial is studying how well Armodafinil works...
<textblock>
<brief_summary>

Detailed Description Detailed Description... <detailed_description>
<textblock>
Detailed Description...
</textblock>
</detailed_description> NA

Primary Objectives

I. To estimate...

<detailed_description>
<textblock>
PRIMARY OBJECTIVES: I. To estimate...
</textblock>
</detailed_description>

Secondary Objectives

I. To obtain a preliminary estimate...

<detailed_description>
<textblock>
SECONDARY OBJECTIVES: To obtain a preliminary estimate...
</textblock>
</detailed_description>

Outline

OUTLINE: This is a multicenter study...

<detailed_description>
<textblock>
OUTLINE: This is a multicenter study...
</textblock>
</detailed_description>

Keywords

Feasibility Armodafinil; narcolepsy

<keyword>Feasibility Armodafinil</keyword>
<keyword>narcolepsy</keyword>

Reporting Dataset Method

Complete

(Not included in the XML file)

Not required for the ClinicalTrials.gov schema

Sponsor

National Cancer Institute

<sponsors>
<lead_sponsor>
<agency>National Cancer Institute</agency>
</lead_sponsor>
</sponsors>

Lead Organization

Wake Forest University Health Sciences

<overall_official>
 <first_name>Jane</first_name>
 <last_name>Doe</last_name>
 <role>Principal Investigator</role>
 <affiliation>Wake Forest University Health Sciences</affiliation>
</overall_official>

Principal Investigator

Jane Doe

<overall_official>
<first_name>Jane</first_name>
<last_name>Doe</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health Sciences</affiliation>
</overall_official>

Responsible Party

Sponsor

<resp_party_type>Sponsor</resp_party_type>

Overall Official

Jane Doe (Principal Investigator) Wake Forest University Health Sciences

<overall_official>
 <first_name>Jane</first_name>
 <last_name>Doe</last_name>
 <role>Principal Investigator</role>
 <affiliation>Wake Forest University Health Sciences</affiliation>
</overall_official>

Current Trial Status

Closed to Accrual and Intervention as of 08/01/2012

<overall_status>Active, not recruiting</overall_status>

Trial Start Date

08/01/2010-Actual

<start_date>2010-08</start_date>
<start_date_type>Actual</start_date_type>

Primary Completion Date

01/11/2014-Actual

<primary_compl_date>2014-01</primary_compl_date>
<primary_compl_date_type>Actual</primary_compl_date_type>

Completion Date

02/04/2014-Actual

<last_follow_up_date>2014-02</last_follow_up_date>

Anchor

	6930
	6930

Info
If no data are available, the "<last_follow_up_date>" does not appear in the XML file.

Not required for the ClinicalTrials.gov schema

Regulatory Information > Studies a U.S. FDA-regulated Drug Product Yes <oversight_info>
<fda_regulated_drug>Yes</fda_regulated_drug>
</oversight_info> NA

Regulatory Information > Studies a U.S. FDA-regulated Device Product Yes <oversight_info>
<fda_regulated_device>Yes</fda_regulated_device>
</oversight_info> NA

Regulatory Information > Unapproved/Uncleared Device?

Yes

<delayed_posting>Yes</delayed_posting>

Regulatory Information > Post Prior to U.S. FDA Approval or Clearance Yes <oversight_info>
<post_prior_to_approval>Yes</post_prior_to_approval>
</oversight_info> NA

Regulatory Information > Pediatric Post-market Surveillance (of a Device Product) Yes <oversight_info>
<ped_postmarket_surv>Yes</ped_postmarket_surv>
</oversight_info> NA

Regulatory Information > Product Exported from the U.S. Yes <oversight_info>
<exported_from_us>Yes</exported_from_us>
</oversight_info> NA

Regulatory Information > FDA Regulated Intervention?

Yes

<is_fda_regulated>Yes</is_fda_regulated>

Regulatory Information > Section 801?

Yes

<is_section_801>Yes</is_section_801>

Regulatory Information > DMC Appointed?

Yes

<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>

Regulatory Information > IND/IDE Study?

Yes

<is_ind_study>Yes</is_ind_study>

Board Approval Status

Submitted, approved

<irb_info>
<approval_status>Approved</approval_status>
</irb_info>

Board Approval Number

IRB00012856

<irb_info>
<approval_number>IRB00012856</approval_number>
</irb_info>

Board

Wake Forest University Health Sciences

<irb_info>
<name>Wake Forest University Health Sciences</name>
</irb_info>

Affiliation

Wake Forest University Health Sciences

<irb_info>
<affiliation>Wake Forest University Health Sciences</affiliation>
</irb_info>

IND/IDE > Type IND <ind_info> Applies to IND and IDE

IND/IDE > Grantor CBER <ind_grantor>CBER</ind_grantor> NA

IND/IDE > Number 119999 <ind_number>119999</ind_number> NA

IND/IDE > Holder Type

NCI

(Not included in the XML file)

IND/IDE > Availability of Expanded Access Yes <has_expanded_access>Yes</has_expanded_access> NA

IND/IDE > Expanded Access Record NCT12345678 <expanded_access_nct_id>NCT12345678</expanded_access_nct_id> NA

NIH Grants > Funding Mechanism

U10

<secondary_id>
<id>U10CA88888</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>

NIH Grants > NIH Institution Code

<secondary_id>
<id>U10CA88888</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>

NIH Grants > Serial Number 88888 <secondary_id>
<id>U10CA88888</id>
<id_type>NIH Grant Number</id_type>
</secondary_id> NA

NIH Grants > NCI Division/Program Code

DCP

(Not included in the XML file)

Data Table 4 Information > Funding Category

Externally Peer-Reviewed

(Not included in the XML file)

Not required for the ClinicalTrials.gov schema

Data Table 4 Information > Funding Sponsor/Source

National Cancer Institute

(Not included in the XML file)

Not required for the ClinicalTrials.gov schema

Data Table 4 Information > Program Codes 2, 5, 12 (Not included in the XML file) NA

Anatomic Site Code

Prostate

(Not included in the XML file)

Not required for the ClinicalTrials.gov schema

Collaborator Name

National Cancer Institute

<collaborator>
<agency>National Cancer Institute</agency>
</collaborator>

Not required for the ClinicalTrials.gov schema

Collaborator Role Funding Source (Not included in the XML file) ClinicalTrials.gov does not capture this field

Disease/Condition Name

Prostate Carcinoma

<condition>Prostate Carcinoma</condition>

Trial Design > Type

Interventional

<study_type>Interventional</study_type>
and
<study_design>Interventional</study_design>

Trial Design > Expanded Access (Not included in the TSR) (Not included in the XML file) Data field in Protocol Abstraction

Trial Design > Primary Purpose

Prevention

<study_design>
<interventional_design>
<interventional_subtype>Prevention</interventional_subtype>
</interventional_design>
</study_design>

Trial Design > Phase

<study_design>
<interventional_design>
<phase>II</phase>
</interventional_design>
</study_design>

Trial Design > Interventional Study Model

Parallel

<study_design>
<interventional_design>
<assignment>Parallel Assignment</assignment>
</interventional_design>
</study_design>

Trial Design > Model Description

Lorem ipsum dolor sit amet ...

<study_design>
<interventional_design>
<model_description>
<textblock>Lorem ipsum dolor sit amet ... </textblock>
</model_description>
</interventional_design>
</study_design>

Trial Design > Number of Arms

<study_design>
<interventional_design>
<number_of_arms>2</number_of_arms>
</interventional_design>
</study_design>

Trial Design > Masking

Participant

: Yes

; Investigator

: Yes

; Care Provider

: Yes

; Outcomes Assessor

: Yes

<study_design>
<interventional_design>
<no_masking>No</no_masking>
<masked_assessor>Yes</masked_assessor>
<masked_caregiver>Yes</masked_caregiver>
<masked_investigator>Yes</masked_investigator>
<masked_subject>Yes</masked_subject>
</interventional_design>
</study_design>

Trial Design > Masking Description

Lorem ipsum dolor sit amet ...

<study_design>
<interventional_design>
<masking_description>
<textblock>Lorem ipsum dolor sit amet ... </textblock>
</masking_description>
</interventional_design>
</study_design>

Trial Design > Allocation

Randomized Controlled Trial

<study_design>
<interventional_design>
<allocation>Randomized Controlled Trial</allocation>
</interventional_design>
</study_design>

Trial Design > Target Enrollment

100

<enrollment>100</enrollment>

Eligibility Criteria > Accepts Healthy Volunteers?

<eligibility>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>

Eligibility Criteria > Sex

Female

<eligibility>
<gender>Female</gender>
</eligibility>

Eligibility Criteria > Gender Based

Yes

<eligibility>
<gender_based>Yes</gender_based>
</eligibility>

Eligibility Criteria > Gender Eligibility Description

Lorem ipsum dolor sit amet ...

<eligibility>
<gender_description>
<textblock>Lorem ipsum dolor sit amet ... </textblock>
</gender_description>
</eligibility>

Eligibility Criteria > Minimum Age

18 Years

<eligibility>
<minimum_age>18 years</minimum_age>
</eligibility>

Eligibility Criteria > Maximum Age

N/A

<eligibility>
<maximum_age>N/A</maximum_age>
</eligibility>

Eligibility Criteria > Inclusion Criteria

Family history of prostate cancer...

<eligibility>
<criteria>
<textblock>Inclusion Criteria: Family history of prostate cancer...</textblock>
</criteria>
</eligibility>

Eligibility Criteria > Exclusion Criteria

Patient must not have had radiation therapy in the pelvic area...

<eligibility>
<criteria>
<textblock>Exclusion Criteria: Patient must not have had radiation therapy in the pelvic area...</textblock>
</criteria>
</eligibility>

Intervention(s) > Type Drug <intervention_type>Drug</intervention_type> NA

Intervention(s) > Name

Armodafinil

<intervention_name>Armodafinil</intervention_name>

Intervention(s) > Alternate Name

2-(difluoromethyl)-DL-ornithine, 2-(difluoromethyl)-dl-ornithine Hydrochloride,...

<intervention_other_name>
2-(difluoromethyl)-DL-ornithine,
2-(difluoromethyl)-dl-ornithine Hydrochloride,...
</intervention_other_name>

Intervention(s) > Description

Given orally

<intervention_description>
<textblock>Given orally</textblock>
</intervention_description>

Arm/Group(s) > Type

Placebo Comparator

<arm_type>Placebo Comparator</arm_type>

Arm/Group(s) > Label

Arm II

<arm_group_label>Arm II</arm_group_label>

Arm/Group(s) > Description

Patients receive oral Armodafinil once daily...

<arm_group_description>
<textblock>Patients receive oral Armodafinil once daily...</textblock>
</arm_group_description>

Primary Outcome Measures > Title

Accrual rate estimated as the number of patients ...

<primary_outcome>
<outcome_measure>Accrual rate estimated as the number of patients ...</outcome_measure>
</primary_outcome>

Primary Outcome Measures > Description Estimated using an analysis of covariance (ANCOVA) model which includes... <outcome_description>
<textblock>Estimated using an analysis of covariance (ANCOVA) model which includes...</textblock>
</outcome_description> NA

Primary Outcome Measures > Time Frame Up to 2 years <outcome_time_frame>Up to 2 years</outcome_time_frame> NA

Secondary Outcome Measures > Title

Incidence of toxicity incidents...

<secondary_outcome>
<outcome_measure>Incidence of toxicity incidents assessed...</outcome_measure>
<secondary_outcome>

Secondary Outcome Measures > Description NA <outcome_description> NA

Secondary Outcome Measures > Time Frame Up to 2 years <outcome_time_frame>Up to 2 years</outcome_time_frame> NA

Sub-groups Stratification Criteria > Label

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol Abstraction

Sub-groups Stratification Criteria > Description

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol Abstraction

Markers > Marker Name

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol Abstraction

Markers > Evaluation Type

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol Abstraction

Markers > Assay Type

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol Abstraction

Markers > Biomarker Use

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol Abstraction

Markers > Biomarker Purpose

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol Abstraction

Markers > Specimen Type

(Not included in the TSR)

(Not included in the XML file)

Data field in Protocol Abstraction

Participating Sites > Facility

Wake Forest University Health Sciences

Winston-Salem, NC 27106

United States

<location>
<facility>
<name>Wake Forest University Health Sciences</name>
<address>
<city>Winston-Salem</city>
<state>NC</state>
<zip>27106</zip>
<country>United States</country>
</address>
</facility>
</location>

Participating Sites > Contact

Doe, Jane, M.

phone:123-123-1234

Email:jmd@domain.com

<location>
<contact>
<first_name>Jane</first_name>
<middle_name>M</middle_name>
<last_name>Doe</last_name>
<phone>123-123-1234</phone>
<email>jmd@domain.com</email>
</contact>
</location>

Participating Sites > Recruitment Status and Dates

Enrolling by Invitation as of 05/09/2014

<location>
<status>Enrolling by Invitation</status>
</location>

Participating Sites > Target Accrual 40 (Not included in the XML file) ClinicalTrials.gov does not capture this field

Participating Sites > Investigators Doe, Jane, Principal Investigator <investigator>
<first_name>Jane</first_name><last_name>Doe</last_name><role>Principal Investigator</role>
</investigator> NA

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