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NCT00769379

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

Version 1531 to 1532 · National Cancer Institute (NCI)

Patch inspector

Version 1531 to 1532

26 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_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2020-01-31",
    "old_value": "2019-03-31",
    "delta_days": 306,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:56:26+00
Raw hash
5cf6faa9d4205eb6b6ffbc30ed473dc523be2a8f78281c7fbbea05f95a10bd39
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 9 ops
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/1
Triage: High
Arm Intervention Change Operation 5
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
ALT02
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/14
Triage: High
Arm Intervention Change Operation 6
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Herzuma
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/19
Triage: High
Arm Intervention Change Operation 7
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Ontruzant
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/24
Triage: High
Arm Intervention Change Operation 8
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Trastuzumab Biosimilar ALT02
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/25
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
trastuzumab biosimilar EG12014
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/29
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Trastuzumab-DTTB
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/30
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Trastuzumab-pkrb
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/31
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Trastuzumab-QYYP
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/32
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Trazimera
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2019-03-31
After
2020-01-31
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 13 ops
replace /protocolSection/contactsLocationsModule/locations/31/facility
Triage: Uncategorized
Uncategorized Operation 14
Before
Feather River Cancer Center
After
Adventist Health Cancer Care Center Chico
replace /protocolSection/contactsLocationsModule/locations/31/zip
Triage: Uncategorized
Uncategorized Operation 15
Before
95928
After
95973
replace /protocolSection/contactsLocationsModule/locations/194/facility
Triage: Uncategorized
Uncategorized Operation 16
Before
Florida Hospital Cancer Institute Altamonte
After
AdventHealth Altamonte
replace /protocolSection/contactsLocationsModule/locations/202/facility
Triage: Uncategorized
Uncategorized Operation 17
Before
Florida Hospital Kissimmee
After
AdventHealth Kissimmee
replace /protocolSection/contactsLocationsModule/locations/206/facility
Triage: Uncategorized
Uncategorized Operation 18
Before
Florida Hospital Orlando
After
AdventHealth Medical Group Urology at Orlando
replace /protocolSection/contactsLocationsModule/locations/207/facility
Triage: Uncategorized
Uncategorized Operation 19
Before
Florida Urology Associates-Orlando
After
AdventHealth Orlando
replace /protocolSection/contactsLocationsModule/locations/209/facility
Triage: Uncategorized
Uncategorized Operation 20
Before
Florida Hospital East Orlando
After
AdventHealth East Orlando
replace /protocolSection/contactsLocationsModule/locations/215/facility
Triage: Uncategorized
Uncategorized Operation 21
Before
Florida Hospital Cancer Institute Winter Park
After
AdventHealth Winter Park
replace /protocolSection/contactsLocationsModule/locations/492/facility
Triage: Uncategorized
Uncategorized Operation 22
Before
The Memorial Hospital at Easton
After
University of Maryland Shore Medical Center at Easton
replace /protocolSection/contactsLocationsModule/locations/516/facility
Triage: Uncategorized
Uncategorized Operation 23
Before
Berkshire Hematology Oncology PC
After
Berkshire Medical Center - Cancer Center
add /protocolSection/contactsLocationsModule/locations/685
Triage: Uncategorized
Uncategorized Operation 24
After
{
  "zip": "68106",
  "city": "Omaha",
  "state": "Nebraska",
  "country": "United States",
  "facility": "Cancer Alliance of Nebraska",
  "geoPoint": {
    "lat": 41.25626,
    "lon": -95.94043
  }
}
replace /protocolSection/contactsLocationsModule/locations/818/facility
Triage: Uncategorized
Uncategorized Operation 25
Before
Atrium Health Union/LCI-Monroe
After
Atrium Health Union/LCI-Union
add /protocolSection/contactsLocationsModule/locations/1264
Triage: Uncategorized
Uncategorized Operation 26
After
{
  "zip": "H2X 3E4",
  "city": "Montreal",
  "state": "Quebec",
  "country": "Canada",
  "facility": "CHUM - Centre Hospitalier de l'Universite de Montreal",
  "geoPoint": {
    "lat": 45.50884,
    "lon": -73.58781
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2018-10
After
2019-06
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2019-04-05
After
2019-06-20
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2019-04-08
After
2019-06-21
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2019-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2020-01-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2019-06-20"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2019-06-21"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/1",
    "value": "ALT02"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/14",
    "value": "Herzuma"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/19",
    "value": "Ontruzant"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/24",
    "value": "Trastuzumab Biosimilar ALT02"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/25",
    "value": "trastuzumab biosimilar EG12014"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/29",
    "value": "Trastuzumab-DTTB"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/30",
    "value": "Trastuzumab-pkrb"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/31",
    "value": "Trastuzumab-QYYP"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/32",
    "value": "Trazimera"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/31/facility",
    "value": "Adventist Health Cancer Care Center Chico"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/31/zip",
    "value": "95973"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/194/facility",
    "value": "AdventHealth Altamonte"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/202/facility",
    "value": "AdventHealth Kissimmee"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/206/facility",
    "value": "AdventHealth Medical Group Urology at Orlando"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/207/facility",
    "value": "AdventHealth Orlando"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/209/facility",
    "value": "AdventHealth East Orlando"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/215/facility",
    "value": "AdventHealth Winter Park"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/492/facility",
    "value": "University of Maryland Shore Medical Center at Easton"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/516/facility",
    "value": "Berkshire Medical Center - Cancer Center"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/685",
    "value": {
      "zip": "68106",
      "city": "Omaha",
      "state": "Nebraska",
      "country": "United States",
      "facility": "Cancer Alliance of Nebraska",
      "geoPoint": {
        "lat": 41.25626,
        "lon": -95.94043
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/818/facility",
    "value": "Atrium Health Union/LCI-Union"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1264",
    "value": {
      "zip": "H2X 3E4",
      "city": "Montreal",
      "state": "Quebec",
      "country": "Canada",
      "facility": "CHUM - Centre Hospitalier de l'Universite de Montreal",
      "geoPoint": {
        "lat": 45.50884,
        "lon": -73.58781
      }
    }
  }
]