NCT03515798
Version 3 to 4 · Institut Paoli-Calmettes
Patch inspector
Manual review pending.
contact_admin_changeenrollment_count_changeenrollment_type_change [
{
"path": "/protocolSection/statusModule/startDateStruct/date",
"signal": "timeline_actual_date_correction",
"category": "timeline_actual_date_correction",
"new_type": "ACTUAL",
"old_type": "ACTUAL",
"severity": "low",
"direction": "later",
"new_value": "2018-08-29",
"old_value": "2018-07-24",
"delta_days": 36,
"date_struct": "startDateStruct",
"new_precision": "day",
"old_precision": "day"
},
{
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"signal": "timeline_major_slip",
"category": "timeline_major_slip",
"new_type": "ACTUAL",
"old_type": "ESTIMATED",
"severity": "medium",
"direction": "later",
"new_value": "2022-08-22",
"old_value": "2020-12-30",
"delta_days": 600,
"date_struct": "primaryCompletionDateStruct",
"new_precision": "day",
"old_precision": "day"
},
{
"path": "/protocolSection/statusModule/completionDateStruct/date",
"signal": "timeline_major_slip",
"category": "timeline_major_slip",
"new_type": "ESTIMATED",
"old_type": "ESTIMATED",
"severity": "medium",
"direction": "later",
"new_value": "2027-08-22",
"old_value": "2025-04-30",
"delta_days": 844,
"date_struct": "completionDateStruct",
"new_precision": "day",
"old_precision": "day"
},
{
"path": "/protocolSection/designModule/enrollmentInfo/count",
"signal": "enrollment_count_change_ge_20pct",
"category": "enrollment_change",
"severity": "high",
"new_value": 52,
"old_value": 81,
"pct_change": 0.358
}
] 21f2c6585571e1fcb7779f680ff10f9bf1bd0a94cb6a6ac1c1be55ef865cb160/protocolSection/designModule/enrollmentInfo/count enrollment_count_change Enrollment count changes can signal scope or feasibility shifts. 81
52
/protocolSection/designModule/enrollmentInfo/type enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority. ESTIMATED
ACTUAL
/protocolSection/statusModule/startDateStruct/date start_timeline_change Start date changes are operational timeline signals. 2018-07-24
2018-08-29
/protocolSection/statusModule/primaryCompletionDateStruct/date primary_completion_timeline_change Primary completion date changes are operational timeline signals. 2020-12-30
2022-08-22
/protocolSection/statusModule/primaryCompletionDateStruct/type primary_completion_timeline_change Primary completion date changes are operational timeline signals. ESTIMATED
ACTUAL
/protocolSection/statusModule/completionDateStruct/date completion_timeline_change Completion date changes are operational timeline signals. 2025-04-30
2027-08-22
/protocolSection/contactsLocationsModule/centralContacts contact_admin_change Central contact updates are usually administrative. [
{
"name": "Dominique GENRE, MD",
"role": "CONTACT",
"email": "drci.up@ipc.unicancer.fr",
"phone": "33 4 91 22 37 78"
},
{
"name": "Margot Berline",
"role": "CONTACT",
"email": "drci.up@ipc.unicancer.fr",
"phone": "33 4 91 22 37 78"
}
] /protocolSection/contactsLocationsModule/locations/0/facility Sint-Augustinus Hospital
Clinique de L'Europe
/protocolSection/contactsLocationsModule/locations/0/status NOT_YET_RECRUITING
/protocolSection/contactsLocationsModule/locations/0/city Antwerp
Amiens
/protocolSection/contactsLocationsModule/locations/0/country Belgium
France
/protocolSection/contactsLocationsModule/locations/0/contacts [
{
"name": "Luc Dirix",
"role": "CONTACT"
},
{
"name": "Dirix",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/0/geoPoint/lat 51.22047
49.9
/protocolSection/contactsLocationsModule/locations/0/geoPoint/lon 4.40026
2.3
/protocolSection/contactsLocationsModule/locations/1/facility Jules Bordet
Institut Sainte Catherine
/protocolSection/contactsLocationsModule/locations/1/status NOT_YET_RECRUITING
/protocolSection/contactsLocationsModule/locations/1/city Brussels
Avignon
/protocolSection/contactsLocationsModule/locations/1/country Belgium
France
/protocolSection/contactsLocationsModule/locations/1/contacts [
{
"name": "Ahmad Awada, Dr",
"role": "CONTACT"
},
{
"name": "Ahmad Awada, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/1/geoPoint/lat 50.85045
43.94834
/protocolSection/contactsLocationsModule/locations/1/geoPoint/lon 4.34878
4.80892
/protocolSection/contactsLocationsModule/locations/2/facility Grand Hôpital de Charleroi
Institut BERGONIE
/protocolSection/contactsLocationsModule/locations/2/status NOT_YET_RECRUITING
/protocolSection/contactsLocationsModule/locations/2/city Charleroi
Bordeaux
/protocolSection/contactsLocationsModule/locations/2/country Belgium
France
/protocolSection/contactsLocationsModule/locations/2/contacts [
{
"name": "Jean-Luc Canon",
"role": "CONTACT"
},
{
"name": "Canon",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/2/geoPoint/lat 50.41136
44.84124
/protocolSection/contactsLocationsModule/locations/2/geoPoint/lon 4.44448
-0.58046
/protocolSection/contactsLocationsModule/locations/3/facility UZ Gand
CENTRE Francois Baclesse
/protocolSection/contactsLocationsModule/locations/3/status NOT_YET_RECRUITING
/protocolSection/contactsLocationsModule/locations/3/city Ghent
Caen
/protocolSection/contactsLocationsModule/locations/3/country Belgium
France
/protocolSection/contactsLocationsModule/locations/3/contacts [
{
"name": "Hannelore Denys",
"role": "CONTACT"
},
{
"name": "Denys",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/3/geoPoint/lat 51.05
49.18585
/protocolSection/contactsLocationsModule/locations/3/geoPoint/lon 3.71667
-0.35912
/protocolSection/contactsLocationsModule/locations/4/facility UCL
Centre Georges Francois Leclerc
/protocolSection/contactsLocationsModule/locations/4/status NOT_YET_RECRUITING
/protocolSection/contactsLocationsModule/locations/4/city Leuven
Dijon
/protocolSection/contactsLocationsModule/locations/4/country Belgium
France
/protocolSection/contactsLocationsModule/locations/4/contacts [
{
"name": "François Duhoux",
"role": "CONTACT"
},
{
"name": "Duhoux",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/4/geoPoint/lat 50.87959
47.31344
/protocolSection/contactsLocationsModule/locations/4/geoPoint/lon 4.70093
5.01391
/protocolSection/contactsLocationsModule/locations/4/zip 21079
/protocolSection/contactsLocationsModule/locations/5/facility CHU Ambroise Pare
Centre Leon Berard
/protocolSection/contactsLocationsModule/locations/5/status NOT_YET_RECRUITING
/protocolSection/contactsLocationsModule/locations/5/city Mons
Lyon
/protocolSection/contactsLocationsModule/locations/5/country Belgium
France
/protocolSection/contactsLocationsModule/locations/5/contacts [
{
"name": "Stephane Holbrechts",
"role": "CONTACT"
},
{
"name": "Holbrechts",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/5/geoPoint/lat 50.45413
45.74906
/protocolSection/contactsLocationsModule/locations/5/geoPoint/lon 3.95229
4.84789
/protocolSection/contactsLocationsModule/locations/6/facility Saint Elisabeth
Institut Curie
/protocolSection/contactsLocationsModule/locations/6/status NOT_YET_RECRUITING
/protocolSection/contactsLocationsModule/locations/6/city Namur
Paris
/protocolSection/contactsLocationsModule/locations/6/country Belgium
France
/protocolSection/contactsLocationsModule/locations/6/contacts [
{
"name": "Peter Vuysteke",
"role": "CONTACT"
},
{
"name": "Vuysteke",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/6/geoPoint/lat 50.4669
48.85341
/protocolSection/contactsLocationsModule/locations/6/geoPoint/lon 4.86746
2.3488
/protocolSection/contactsLocationsModule/locations/7/facility Clinique de L'Europe
Centre Henri Becquerel
/protocolSection/contactsLocationsModule/locations/7/status RECRUITING
/protocolSection/contactsLocationsModule/locations/7/city Amiens
Rouen
/protocolSection/contactsLocationsModule/locations/7/contacts [
{
"name": "GOZY",
"role": "CONTACT"
},
{
"name": "GOZY, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/7/geoPoint/lat 49.9
49.44313
/protocolSection/contactsLocationsModule/locations/7/geoPoint/lon 2.3
1.09932
/protocolSection/contactsLocationsModule/locations/8/facility Institut Sainte Catherine
Institut Curie hopital rene huguenin
/protocolSection/contactsLocationsModule/locations/8/status RECRUITING
/protocolSection/contactsLocationsModule/locations/8/city Avignon
Saint-Cloud
/protocolSection/contactsLocationsModule/locations/8/contacts [
{
"name": "Julien GRENIER, Dr",
"role": "CONTACT"
},
{
"name": "Julien GRENIER, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/8/geoPoint/lat 43.94834
48.84598
/protocolSection/contactsLocationsModule/locations/8/geoPoint/lon 4.80892
2.20289
/protocolSection/contactsLocationsModule/locations/9/facility Institut BERGONIE
Institut de cancérologie de la loire
/protocolSection/contactsLocationsModule/locations/9/status RECRUITING
/protocolSection/contactsLocationsModule/locations/9/city Bordeaux
Saint-Priest-en-Jarez
/protocolSection/contactsLocationsModule/locations/9/contacts [
{
"name": "Camille CHAKIBA-BRUGERE, Dr",
"role": "CONTACT"
},
{
"name": "Camille CHAKIBA-BRUGERE, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/9/geoPoint/lat 44.84124
45.4739
/protocolSection/contactsLocationsModule/locations/9/geoPoint/lon -0.58046
4.37678
/protocolSection/contactsLocationsModule/locations/10/facility CENTRE Francois Baclesse
Centre Paul Strauss
/protocolSection/contactsLocationsModule/locations/10/status RECRUITING
/protocolSection/contactsLocationsModule/locations/10/city Caen
Strasbourg
/protocolSection/contactsLocationsModule/locations/10/contacts [
{
"name": "Christelle LEVY, Dr",
"role": "CONTACT"
},
{
"name": "Christelle LEVY",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/10/geoPoint/lat 49.18585
48.58392
/protocolSection/contactsLocationsModule/locations/10/geoPoint/lon -0.35912
7.74553
/protocolSection/contactsLocationsModule/locations/11/facility Centre Leon Berard
IUCT-Oncopole Institut Claudius Rigaud
/protocolSection/contactsLocationsModule/locations/11/status RECRUITING
/protocolSection/contactsLocationsModule/locations/11/city Lyon
Toulouse
/protocolSection/contactsLocationsModule/locations/11/contacts [
{
"name": "Thomas BACHELOT, Dr",
"role": "CONTACT"
},
{
"name": "Thomas BACHELOT, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
] /protocolSection/contactsLocationsModule/locations/11/geoPoint/lat 45.74906
43.60426
/protocolSection/contactsLocationsModule/locations/11/geoPoint/lon 4.84789
1.44367
/protocolSection/contactsLocationsModule/locations/12 {
"city": "Paris",
"status": "RECRUITING",
"country": "France",
"contacts": [
{
"name": "Florence LEREBOURS, Dr",
"role": "CONTACT"
},
{
"name": "Florence Lerebours, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"facility": "Institut Curie",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
}
} /protocolSection/contactsLocationsModule/locations/12 {
"city": "Rouen",
"status": "RECRUITING",
"country": "France",
"contacts": [
{
"name": "Marianne LEHEURTEUR, Dr",
"role": "CONTACT"
},
{
"name": "Marianne LEHEURTEUR, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"facility": "Centre Henri Becquerel",
"geoPoint": {
"lat": 49.44313,
"lon": 1.09932
}
} /protocolSection/contactsLocationsModule/locations/12 {
"city": "Saint-Cloud",
"status": "RECRUITING",
"country": "France",
"contacts": [
{
"name": "Florence Lerebours, Dr",
"role": "CONTACT"
},
{
"name": "Florence Lerebours",
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"facility": "Institut Curie hopital rene huguenin",
"geoPoint": {
"lat": 48.84598,
"lon": 2.20289
}
} /protocolSection/contactsLocationsModule/locations/12 {
"city": "Saint-Priest-en-Jarez",
"status": "RECRUITING",
"country": "France",
"contacts": [
{
"name": "Jean-Philippe JACQUIN, Pr",
"role": "CONTACT"
},
{
"name": "Jean-Philippe JACQUIN, Pr",
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"facility": "Institut de cancérologie de la loire",
"geoPoint": {
"lat": 45.4739,
"lon": 4.37678
}
} /protocolSection/contactsLocationsModule/locations/12 {
"city": "Strasbourg",
"status": "RECRUITING",
"country": "France",
"contacts": [
{
"name": "Thierry PETIT, Pr",
"role": "CONTACT"
},
{
"name": "Thierry PETIT, Pr",
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"facility": "Centre Paul Strauss",
"geoPoint": {
"lat": 48.58392,
"lon": 7.74553
}
} /protocolSection/contactsLocationsModule/locations/12 {
"city": "Toulouse",
"status": "RECRUITING",
"country": "France",
"contacts": [
{
"name": "Florence DALENC, Dr",
"role": "CONTACT"
},
{
"name": "Florence DALENC, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"facility": "IUCT-Oncopole Institut Claudius Rigaud",
"geoPoint": {
"lat": 43.60426,
"lon": 1.44367
}
} /protocolSection/statusModule/statusVerifiedDate 2020-06
2024-07
/protocolSection/statusModule/lastUpdateSubmitDate 2020-06-30
2024-07-25
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2020-07-02
2024-07-26
/protocolSection/statusModule/overallStatus RECRUITING
ACTIVE_NOT_RECRUITING
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2024-07"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "ACTIVE_NOT_RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/startDateStruct/date",
"value": "2018-08-29"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2022-08-22"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
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},
{
"op": "replace",
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},
{
"op": "replace",
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"value": "2024-07-26"
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 52
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "remove",
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},
{
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{
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{
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{
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{
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