CAT-01

2024-517594-24-01 Phase I and Phase II (Integrated) - Other Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other
Status Authorised, recruitment pending
Participants planned 20
Countries 1
Sites 1

Cervical carcinoma

Key facts

Sponsor
Karolinska Institutet
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Decision date (initial)
2026-03-09
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Cervical carcinoma

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska Institutet

Sponsor organisation
Karolinska Institutet
Address
Nobels Vag 6
City
Solna
Postcode
171 65
Country
Sweden

Scientific contact point

Organisation
Karolinska Institutet
Contact name
Stina Wickström

Public contact point

Organisation
Karolinska Institutet
Contact name
Stina Wickström

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Authorised, recruitment pending 20 1
Rest of world 0

Investigational sites

Sweden

1 site · Authorised, recruitment pending
Karolinska University Hospital
Pelvic Cancer, Eugeniavagen 3, 171 64, Solna

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-10-09 Sweden Acceptable
2026-03-09
2026-03-09