Back to trial

NCT00165256

Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast

Version 7 to 8 · Dana-Farber Cancer Institute

Patch inspector

Version 7 to 8

17 operations 4 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
arms_or_interventions_changedesign_info_changephase_changewhy_stopped_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/whyStopped",
    "signal": "why_stopped_empty",
    "category": "status_termination",
    "severity": "critical"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "high",
    "direction": "later",
    "new_value": "2019-11",
    "old_value": "2017-04",
    "delta_days": 944,
    "date_struct": "completionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:10:55+00
Raw hash
6baad01ff0e88261b21d799435501a2ebf5ddaffe8f18b0cf0c504a82a201b57
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 10 ops
replace /protocolSection/designModule/studyType
Triage: Uncategorized
Uncategorized Operation 8
Before
OBSERVATIONAL
After
INTERVENTIONAL
remove /protocolSection/designModule/patientRegistry
Triage: Uncategorized
Uncategorized Operation 9
Before
false
remove /protocolSection/designModule/designInfo/observationalModel
Triage: High
Design Change Operation 10
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
CASE_ONLY
remove /protocolSection/designModule/designInfo/timePerspective
Triage: High
Design Change Operation 11
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
PROSPECTIVE
add /protocolSection/designModule/designInfo/allocation
Triage: High
Design Change Operation 12
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
NA
add /protocolSection/designModule/designInfo/interventionModel
Triage: High
Design Change Operation 13
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
SINGLE_GROUP
add /protocolSection/designModule/designInfo/primaryPurpose
Triage: High
Design Change Operation 14
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
OTHER
add /protocolSection/designModule/designInfo/maskingInfo
Triage: High
Design Change Operation 15
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
{
  "masking": "NONE"
}
add /protocolSection/designModule/phases
Triage: High
Design Change Operation 16
Matched rules
  • phase_change Trial phase changes are high review-priority design changes.
After
[
  "PHASE2"
]
add /protocolSection/armsInterventionsModule/armGroups/0/type
Triage: High
Arm Intervention Change Operation 17
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
EXPERIMENTAL
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: High 2 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 2
Before
TERMINATED
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/statusModule/whyStopped
Triage: High
Status Termination Operation 3
Matched rules
  • why_stopped_change Why-stopped changes explain discontinuation and need review.
Before
The pre-specified stopping boundary was reached.
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2017-04
After
2019-11
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2016-07
After
2018-11
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2016-07-05
After
2018-11-02
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2016-07-06
After
2018-11-05
replace /protocolSection/statusModule/lastUpdatePostDateStruct/type
Triage: Uncategorized
Uncategorized Operation 7
Before
ESTIMATED
After
ACTUAL
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2018-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "remove",
    "path": "/protocolSection/statusModule/whyStopped"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2019-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2018-11-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2018-11-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/studyType",
    "value": "INTERVENTIONAL"
  },
  {
    "op": "remove",
    "path": "/protocolSection/designModule/patientRegistry"
  },
  {
    "op": "remove",
    "path": "/protocolSection/designModule/designInfo/observationalModel"
  },
  {
    "op": "remove",
    "path": "/protocolSection/designModule/designInfo/timePerspective"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/allocation",
    "value": "NA"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/interventionModel",
    "value": "SINGLE_GROUP"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/primaryPurpose",
    "value": "OTHER"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/maskingInfo",
    "value": {
      "masking": "NONE"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/phases",
    "value": [
      "PHASE2"
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/type",
    "value": "EXPERIMENTAL"
  }
]