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NCT03535506

Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery

Version 6 to 7 · Georgetown University

Patch inspector

Version 6 to 7

12 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
contact_admin_changeenrollment_count_changeenrollment_type_change
Value signals
[
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 17,
    "old_value": 24,
    "pct_change": 0.2917
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:01+00
Raw hash
6352310ac31fc2418bf88ac54da392e95865d7a7a10ce68f394e984b8c4b1317
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 5
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
24
After
17
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 6
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ESTIMATED
After
ACTUAL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 6 ops
remove /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 7
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
[
  {
    "name": "Candace Mainor, MD",
    "role": "CONTACT",
    "email": "Candace.Mainor@gunet.georgetown.edu",
    "phone": "202-444-2223"
  },
  {
    "name": "Antonella Novielli, RN, MSN",
    "role": "CONTACT",
    "email": "noviella@georgetown.edu",
    "phone": "202-784-3923"
  }
]
remove /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 8
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 9
Before
[
  {
    "name": "Nellie Novielli, RN",
    "role": "CONTACT",
    "email": "noviella@georgetown.edu",
    "phone": "202-784-3923"
  },
  {
    "name": "Candace Mainor, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/1/status
Triage: Uncategorized
Uncategorized Operation 10
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/1/contacts
Triage: Uncategorized
Uncategorized Operation 11
Before
[
  {
    "name": "Stacy Malloy",
    "role": "CONTACT",
    "email": "stacy.k.malloy@medstar.net",
    "phone": "202-877-9374"
  },
  {
    "name": "Christopher Gallagher, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
add /protocolSection/contactsLocationsModule/overallOfficials
Triage: Uncategorized
Uncategorized Operation 12
After
[
  {
    "name": "Candace Mainor, MD",
    "role": "PRINCIPAL_INVESTIGATOR",
    "affiliation": "Georgetown University"
  }
]
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
2023-01
After
2023-12
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2023-01-23
After
2023-12-15
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2023-01-25
After
2023-12-18
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 2
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-12-15"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-12-18"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 17
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ACTUAL"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/centralContacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/contacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1/contacts"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/overallOfficials",
    "value": [
      {
        "name": "Candace Mainor, MD",
        "role": "PRINCIPAL_INVESTIGATOR",
        "affiliation": "Georgetown University"
      }
    ]
  }
]