NCT06800612

Brief Summary

retrospective/prospective observational study. Objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
57mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Mar 2024Dec 2030

Study Start

First participant enrolled

March 22, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 30, 2025

Status Verified

December 1, 2024

Enrollment Period

6.8 years

First QC Date

December 27, 2024

Last Update Submit

January 28, 2025

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Breast Cancer MetastaticOvarian CancerCervical CarcinomaEndometrial Cancer

Keywords

observationalbreast cancergynecologic cancerovarian cancercervical carcinomaendometrial cancer

Outcome Measures

Primary Outcomes (1)

  • DFS

    To evaluate effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: disease-free survival (DFS)

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Secondary Outcomes (3)

  • PFS

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

  • OS

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

  • Side effects

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Study Arms (2)

retrospective cohort

In this cohort data will be recorded retrospectively

Drug: Oncologic drugs administered for treatment of breast cancerDrug: Oncologic drug administered for treatment of gynecologic cancer

prospective cohort

In this cohort data will be recorded prospectively

Drug: Oncologic drugs administered for treatment of breast cancerDrug: Oncologic drug administered for treatment of gynecologic cancer

Interventions

Oncologic drugs administered for treatment of breast cancerDRUG

Data on oncologic drugs administered for treatment of breast cancer will be recorded

prospective cohortretrospective cohort
Oncologic drug administered for treatment of gynecologic cancerDRUG

Data on oncologic drugs administered for treatment of gynecologic cancer will be recorded

prospective cohortretrospective cohort

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated for breast or gynecologic cancer from January 2010.

You may qualify if:

  • Diagnosis of histologically confirmed breast cancer or gynecological cancer, either early stage or metastatic;
  • Patients who have received treatment for breast cancer or gynecologic cancer since January 2010;
  • Any patient currently living and actually contactable must sign an informed consent to the study and processing of personal data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Claudio Zamagni, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Zamagni, MD

CONTACT

0512144548zamagniclaudio.sper@aosp.bo.it

Cinzia Pizzirani, PhD

CONTACT

0512144447cinzia.pizzirani@aosp.bo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 30, 2025

Study Start

March 22, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

January 30, 2025

Record last verified: 2024-12

Locations

IT(1)