Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-30 @ 9:31 PM
Study NCT ID:
NCT06771193
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2025-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Disease Characteristics and Treatment in Locally Advanced or Recurrent / Metastatic Cervical Cancer in Italy
Sponsor:
MSD Italia S.r.l.
Organization:
Study Overview
Official Title:
RETRACE Study - Retrospective Observational Study Evaluating Disease Characteristics and Treatment Landscape of High-risk Locally Advanced (LA) or Recurrent / Metastatic (R/M) Cervical Cancer in Italy
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETRACE
Brief Summary:
Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed.
Detailed Description:
This is a multicenter, observational, retrospective study. The primary aim of this trial is to describe patients and disease characteristics, as well as treatment pattern of locally advanced and recurrent/metastatic cervical cancer (R/M and LACC) in Italy, through a retrospective data capture, from January 2018 to December 2021.
Eligible cervical cancer patients will be identified by reviewing medical records and physician notes (paper or electronic).
Disease will be defined as follow:
* Locally advanced cervical cancer: a large tumour within the cervix (more than 4cm) or it has grown into the tissues around the cervix, but the cancer has not spread to other organs; usually includes stage 2B, 3 and 4A (FIGO staging)
* Recurrent cervical cancer: local tumour regrowth or development of distant metastasis discovered 6 months or more after complete regression of the treatment (26)
* Metastatic cervical cancer: cancer spreads beyond the pelvis to other parts of the body; usually defined as stage 4B (FIGO staging) Moreover, the patients' characteristics will be stratified as low risk and high risk for locally advanced cervical cancer and differences between their treatment partners will be reported.
Eligible cervical cancer patients will be identified by reviewing medical records and physician notes (paper or electronic).
Disease will be defined as follow:
* Locally advanced cervical cancer: a large tumour within the cervix (more than 4cm) or it has grown into the tissues around the cervix, but the cancer has not spread to other organs; usually includes stage 2B, 3 and 4A (FIGO staging)
* Recurrent cervical cancer: local tumour regrowth or development of distant metastasis discovered 6 months or more after complete regression of the treatment (26)
* Metastatic cervical cancer: cancer spreads beyond the pelvis to other parts of the body; usually defined as stage 4B (FIGO staging) Moreover, the patients' characteristics will be stratified as low risk and high risk for locally advanced cervical cancer and differences between their treatment partners will be reported.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: