Clinical Trials Register

Summary
EudraCT Number:	2019-001088-58
Sponsor's Protocol Code Number:	SELLY
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-08-31
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-001088-58

A.3

Full title of the trial

SEntinel Lymph node in EarLY ovarian cancer: the SELLY protocol

Accuratezza del Linfonodo Sentinella nel Carcinoma Ovarico Iniziale: il protocollo SELLY

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

SEntinel Lymph node in EarLY ovarian cancer: the SELLY protocol

Accuratezza del Linfonodo Sentinella nel Carcinoma Ovarico Iniziale: il protocollo SELLY

A.3.2

Name or abbreviated title of the trial where available

SELLY

A.4.1

Sponsor's protocol code number

SELLY

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Margherita Zona
B.5.2	Functional name of contact point	Direzione Scientifica IRCCS
B.5.3	Address:
B.5.3.1	Street Address	L.go A. Gemelli 8
B.5.3.2	Town/ city	Roam
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39063015570
B.5.6	E-mail	margherita.zona@policlinicogemelli.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	VERDE INDOCIANINA PULSION - 5MG/ML POLVERE PER SOLUZIONE INIETTABILE 5 FLACONCINI DI VETRO CONTENENTI 25 MG DI POLVERE
D.2.1.1.2	Name of the Marketing Authorisation holder	PULSION MEDICAL SYSTEMS AG
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	VERDE INDOCIANINA
D.3.2	Product code	[V04CX01]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralymphatic use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	3599-32-4
D.3.9.2	Current sponsor code	036930028
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

ADVANCED OVARIAN CANCER

CARCINOMA OVARICO IN FASE AVANZATA

E.1.1.1

Medical condition in easily understood language

ADVANCED OVARIAN CANCER

CARCINOMA OVARICO IN FASE AVANZATA

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10070906
E.1.2	Term	Ovarian cancer stage II
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10070905
E.1.2	Term	Ovarian cancer stage I
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The aim of the present study is to investigate the diagnostic accuracy of sentinel node (SLN) technique in apparent early EOC, using indocyanine green (ICG), injected in the ovarian ligaments.

Lo scopo del presente studio è quello di indagare l'accuratezza diagnostica del linfonodo sentinella (SLN) in apparente EOC precoce, utilizzando il verde indocianina (ICG), iniettato nei legamenti ovarici.

E.2.2

Secondary objectives of the trial

Detection rate of sentinel node technique (SLN) and its safety

Tasso di rilevamento della tecnica del linfonodo sentinella (SLN) e sua sicurezza

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: 1. miRNome Next Generation Sequencing from Exosome/microvesicles preparations;
2. Immunoassay-based dosage of circulating levels of VEGF-C and SEMA4C protein markers
released by lymph-nodal metastatic lesions.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: 1.Sequenziamento di miRNome da preparati di esosomi / microvescicole;
2. Dosaggio basato sull'analisi immunologica dei livelli circolanti di marcatori proteici VEGF-C e SEMA4C rilasciati da lesioni metastatiche linfonodali.

E.3

Principal inclusion criteria

1. Diagnosis of EOC macroscopically limited to the ovaries or the pelvis (surgical stage I-II)
2. Surgical staging
3. Age between 18 and 80
4. Performance Status (ECOG) <= 2, an adequate respiratory, hepatic, cardiac, bone marrow, liver and renal function (Creatinine Clearance > 60 mL/min according to Cockroft formula)
5. Negative preoperative CT scan imaging for positive nodes (defined as lymph modes < 1cm in their larger axis).

1. Diagnosi di EOC macroscopicamente limitata alle ovaie o al bacino (stadio chirurgico I-II)
2. Stadiazione chirurgica
3. Età tra 18 e 80 anni
4. Performance Status (ECOG) <= 2, un adeguato sistema respiratorio, epatico, cardiaco, midollo osseo, fegato e funzionalità renale (Clearance della creatinina> 60 ml / min secondo la formula di Cockroft)
5. TAC preoperatoria negativa per linfonodi patologici (definiti come modalità linfatiche <1 cm nel loro asse maggiore).

E.4

Principal exclusion criteria

1. FIGO stages III B, III C or IV
2. Mucinous histology
3. Previous surgery of the aorta, caval vein, and/or iliac vessels
4. Previous lymphadenectomy or lymph node sampling in the iliac or para-aortic region that could change the ovarian lymphatic drainage
5. Hepatic dysfunction defined as a Model for End-Stage Liver Disease score of 10 or greater, renal dysfunction defined as serum creatinine of 2.0 mg/dL or greater
6. Usage of any other tracer but ICG
7. History of allergy to ICG, iodine, iodine dyes, isosulfan blue, or triphenylmethane
8. History of a malignant lymphoma
9. History of a malignant tumor in the abdominal cavity
10. Concomitant other malignancies
11. Previous abdominal radiation therapy
12. Pregnancy or lactation
13. Refusal to provide written informed consent

1. Stadio FIGO III B, III C o IV
2. Istologia mucinosa
3. Precedente chirurgia aorta, vena cavale e / o vasi iliaci
4. Precedente linfoadenectomia o campionamento linfonodale nella regione iliaca o para-aortica che potrebbe modificare il drenaggio linfatico ovarico
5. Disfunzione epatica definita come un modello di punteggio di malattia epatica allo stadio terminale di 10 o più, disfunzione renale definita come creatinina sierica di 2,0 mg / dL o superiore
6. Utilizzo di qualsiasi altro tracciante oltre ICG
7. Storia di allergia a ICG, iodio, coloranti di iodio, isosulfan blu o trifenilmetano
8. Storia di un lymphoma maligno
9. Storia di un tumore maligno nella cavità addominale
10. Altri tumori maligni concomitanti
11. Precedente radioterapia addominale
12. Gravidanza o allattamento
13. Rifiuto di fornire il consenso informato scritto

E.5 End points

E.5.1

Primary end point(s)

Specificity of the SLN analysis in predicting the positive lymphatic status at histology of apparent early stage EOC.

Specificità dell'analisi del linfonodo sentinella nel predire lo stato linfatico positivo all'istologia dell'EOC in stadio iniziale.

E.5.1.1

Timepoint(s) of evaluation of this end point

41 months

41 mesi

E.5.2

Secondary end point(s)

1. Detection rate of SLN in order to assess the feasibility of the procedure; 2. Complications rate of the procedure

1. Tasso di rilevamento di SLN al fine di valutare la fattibilità della procedura; 2. Tasso di complicanze della procedura

E.5.2.1

Timepoint(s) of evaluation of this end point

41 months; 41 months

41 mesi; 41 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Diagnostic accuracy in terms of specificity and sensitivity

Accuratezza diagnostica in termini di specificità e sensibilità

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-08-31.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

176

F.4.2

For a multinational trial

F.4.2.1

In the EEA

176

F.4.2.2

In the whole clinical trial

176

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

general clinical practice

Normale pratica clinica

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-03-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-12-04

P. End of Trial
P.	End of Trial Status	Ongoing

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