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NCT01224678

Vitamin D and Breast Cancer Biomarkers in Female Patients

Version 107 to 108 · Alliance for Clinical Trials in Oncology

Patch inspector

Version 107 to 108

25 operations 7 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
design_info_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2014-12",
    "old_value": "2014-10",
    "delta_days": 61,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:14:57+00
Raw hash
c53f72ab90fa1f9777d551a177ce5af5ab5d08641da8132f411fa6e9fd45147c
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops
add /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 18
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
Up to 12 months
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops
add /protocolSection/designModule/designInfo/maskingInfo/whoMasked
Triage: High
Design Change Operation 16
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
[
  "PARTICIPANT",
  "INVESTIGATOR"
]
add /protocolSection/designModule/designInfo/interventionModel
Triage: High
Design Change Operation 17
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
PARALLEL
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 6 ops
add /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 19
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Up to 12 months
add /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 20
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Up to 12 months
replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure
Triage: High
Secondary Outcome Change Operation 21
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Correlations between change in breast cancer biomarkers (density, IGF1, atypia, and Ki67) with each other and with change in vitamin D levels and vitamin D-receptor expression
After
Comparison among 3 methods of breast density determination
add /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 22
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Up to 12 months
remove /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 23
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "Validation of Sunlight Questionnaire"
}
remove /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 24
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "Comparison among 3 methods of breast density determination"
}
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 7
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2014-10
After
2014-12
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 8
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2013-02
After
2015-07
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 9
Before
2013-02-05
After
2015-07-09
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 10
Before
2013-02-06
After
2015-07-10
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 10 ops
replace /protocolSection/identificationModule/orgStudyIdInfo/id
Triage: Uncategorized
Uncategorized Operation 1
Before
CDR0000687263
After
CALGB-70806
add /protocolSection/identificationModule/secondaryIdInfos/1
Triage: Uncategorized
Uncategorized Operation 2
After
{
  "id": "CDR0000687263",
  "type": "REGISTRY",
  "domain": "NCI Physician Data Query"
}
replace /protocolSection/identificationModule/organization/fullName
Triage: Uncategorized
Uncategorized Operation 3
Before
National Cancer Institute (NCI)
After
Alliance for Clinical Trials in Oncology
replace /protocolSection/identificationModule/organization/class
Triage: Uncategorized
Uncategorized Operation 4
Before
NIH
After
OTHER
remove /protocolSection/sponsorCollaboratorsModule/responsibleParty/oldNameTitle
Triage: Uncategorized
Uncategorized Operation 11
Before
Monica M. Bertagnolli
remove /protocolSection/sponsorCollaboratorsModule/responsibleParty/oldOrganization
Triage: Uncategorized
Uncategorized Operation 12
Before
Cancer and Leukemia Group B
add /protocolSection/sponsorCollaboratorsModule/responsibleParty/type
Triage: Uncategorized
Uncategorized Operation 13
After
SPONSOR
replace /protocolSection/sponsorCollaboratorsModule/leadSponsor/name
Triage: Uncategorized
Uncategorized Operation 14
Before
Cancer and Leukemia Group B
After
Alliance for Clinical Trials in Oncology
replace /protocolSection/sponsorCollaboratorsModule/leadSponsor/class
Triage: Uncategorized
Uncategorized Operation 15
Before
NETWORK
After
OTHER
add /protocolSection/oversightModule
Triage: Uncategorized
Uncategorized Operation 25
After
{
  "oversightHasDmc": false
}
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: Uncategorized 1 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 6
Before
SUSPENDED
After
ACTIVE_NOT_RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/orgStudyIdInfo/id",
    "value": "CALGB-70806"
  },
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/1",
    "value": {
      "id": "CDR0000687263",
      "type": "REGISTRY",
      "domain": "NCI Physician Data Query"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/organization/fullName",
    "value": "Alliance for Clinical Trials in Oncology"
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/organization/class",
    "value": "OTHER"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2015-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2014-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-07-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-07-10"
  },
  {
    "op": "remove",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/oldNameTitle"
  },
  {
    "op": "remove",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/oldOrganization"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/type",
    "value": "SPONSOR"
  },
  {
    "op": "replace",
    "path": "/protocolSection/sponsorCollaboratorsModule/leadSponsor/name",
    "value": "Alliance for Clinical Trials in Oncology"
  },
  {
    "op": "replace",
    "path": "/protocolSection/sponsorCollaboratorsModule/leadSponsor/class",
    "value": "OTHER"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/maskingInfo/whoMasked",
    "value": [
      "PARTICIPANT",
      "INVESTIGATOR"
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/interventionModel",
    "value": "PARALLEL"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Up to 12 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "Up to 12 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "Up to 12 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Comparison among 3 methods of breast density determination"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "Up to 12 months"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3"
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule",
    "value": {
      "oversightHasDmc": false
    }
  }
]