Montag, 6. Mai 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE

Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy

Rekrutierend

NCT-Nummer:
NCT04813627

Studienbeginn:
Juli 2021

Letztes Update:
11.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
BioNTech SE

Collaborator:
-

Studienleiter

BioNTech Responsible Person
Study Director
BioNTech SE

Kontakt

BioNTech clinical trials patient information
Kontakt:
Phone: +49 6131 9084
E-Mail: patients@biontech.de» Kontaktdaten anzeigen

Studienlocations
(3 von 73)

Gemeinschaftspraxis Dr. med. B. Heinrich, Prof. M. Bangerter MD
86150 Augsburg
(Bayern)
GermanyRekrutierend» Google-Maps
Charité Campus Mitte (CCM) - Universitätsmedizin Berlin
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum St. Josef-Hospital Bochum
44791 Bochum
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Medizinische Klinik III, Universitätsklinikum Bonn
53127 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Cancer Center Donauwoerth and Dachau
86609 Donauwoerth
(Bayern)
GermanyRekrutierend» Google-Maps
St. Johannes Hospital
44137 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Asklepios MVZ Elmshorn
25335 Elmshorn
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Centrum fuer Haematologie und Onkologie Bethanien
60389 Frankfurt am Main
(Hessen)
GermanyRekrutierend» Google-Maps
Gynäkologisches Krebszentrum Agaplesion Markus Krankenhaus Frankfurt
Wilhelm-Epstein-Straße 4
60431 Frankfurt am Main
DeutschlandRekrutierend» Google-Maps
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung
60488 Frankfurt am Main
(Hessen)
GermanyRekrutierend» Google-Maps
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
60590 Frankfurt am Main
(Hessen)
GermanyRekrutierend» Google-Maps
Studiengesellschaft BSF
06108 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Asklepios Klinik St. Georg
20099 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Haematologisch-Onkologische Praxis Eppendorf HOPE
20249 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Asklepios Kliniken Nord
22417 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Asklepios Klinik Altona
22763 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandRekrutierend» Google-Maps
SLK-Kliniken Heilbronn GmbH
74078 Heilbronn
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Internistische Schwerpunktpraxis Hamatologie und Onkologie
55122 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ze:ro Arztpraxen
68165 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Klinikum der Universität München, Medizinische Klinik und Poliklinik III
81377 München
(Bayern)
GermanyRekrutierend» Google-Maps
Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach
81737 München
(Bayern)
GermanyRekrutierend» Google-Maps
Prosper Hospital
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsmedizin Rostock
18057 Rostock
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Ulm
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Asklepios Klinik Weissenfels
06667 Weißenfels
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Helios Dr. Horst Schmidt Kliniken (HSK)
65199 Wiesbaden
(Hessen)
GermanyRekrutierend» Google-Maps
Forschungszentrum Ruhr
58455 Witten
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ridley-Tree Cancer Center
93105 California City
United StatesRekrutierend» Google-Maps
John Muir Clinical Research Center
94520 Concord
United StatesRekrutierend» Google-Maps
The Oncology Institute of Hope
90033 Los Angeles
United StatesRekrutierend» Google-Maps
Rocky Mountain Cancer Centers - Denver Midtown
80218 Denver
United StatesRekrutierend» Google-Maps
Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur
62526 Decatur
United StatesRekrutierend» Google-Maps
Orchard Healthcare Research Inc.
60077 Skokie
United StatesRekrutierend» Google-Maps
USOR - New York Oncology Hematology, P.C.
12206 Albany
United StatesRekrutierend» Google-Maps
Oncology Hematology Care Clinical Trials, LLC
45245 Cincinnati
United StatesRekrutierend» Google-Maps
USOR - Willamette Valley Cancer Institute and Research Center
97401 Eugene
United StatesRekrutierend» Google-Maps
Texas Oncology - Austin
78705 Austin
United StatesRekrutierend» Google-Maps
Texas Oncology - Baylor Charles A. Sammons Cancer Center
75246 Dallas
United StatesRekrutierend» Google-Maps
Texas Oncology - San Antonio Medical Center
78229 San Antonio
United StatesRekrutierend» Google-Maps
Texas Oncology - Northeast Texas
75702 Tyler
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists, PC
22031 Fairfax
United StatesRekrutierend» Google-Maps
Rockwood Cancer Treatment Center
99204 Spokane
United StatesRekrutierend» Google-Maps
Northwest Cancer Specialists
98684 Vancouver
United StatesRekrutierend» Google-Maps
VZW Algemeen Ziekenhuis KLINA
2930 Brasschaat
BelgiumRekrutierend» Google-Maps
Algemeen Ziekenhuis Sint-Lucas
8310 Brugge
BelgiumRekrutierend» Google-Maps
Universitair Ziekenhuis Brussel (UZ-VUB - Academisch Ziekenhuis)
1090 Jette
BelgiumRekrutierend» Google-Maps
Centres Hospitaliers Jolimont
7100 La Louvière
BelgiumRekrutierend» Google-Maps
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
3000 Leuven
BelgiumRekrutierend» Google-Maps
Clinique et Maternite Sainte-Elisabeth (CMSE)
5000 Namur
BelgiumRekrutierend» Google-Maps
Clinique Saint-Pierre d'ottignies (CSPO)
1340 Ottignies
BelgiumRekrutierend» Google-Maps
Algemeen Ziekenhuis (AZ) Glorieux
9600 Ronse
BelgiumRekrutierend» Google-Maps
Centre Hospitalier Regional, CHR
4800 Verviers
BelgiumRekrutierend» Google-Maps
Complejo Hospitalario Universitario A Coruna
15006 A Coruña
SpainRekrutierend» Google-Maps
Hospital Universitari Germans Trias - ICO Badalona
08916 Badalona
SpainRekrutierend» Google-Maps
IOR- Instituto Quiron Dexeus
08028 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital de la Santa Creu i Sant Pau
08041 Barcelona
SpainRekrutierend» Google-Maps
Hospital De Sant Joan Despi Moises Broggi
08970 Barcelona
SpainRekrutierend» Google-Maps
Hospital General De Granollers
08402 Granollers
SpainRekrutierend» Google-Maps
Hospital Sant Joan de Deu-Fundacio Althaia
08243 Manresa
SpainRekrutierend» Google-Maps
Complejo Hospitalario de Orense
32005 Orense
SpainRekrutierend» Google-Maps
Complejo Hospitalario de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitari Sant Joan de Reus
43204 Reus
SpainRekrutierend» Google-Maps
Corporacio Sanitaria Universitaria Parc Tauli
08208 Sabadell
SpainRekrutierend» Google-Maps
Complejo Hospitalario Universitario De Santiago De Compostela
15706 Santiago De Compostela
SpainRekrutierend» Google-Maps
Hospital Universitario Mutua de Terrassa
08222 Terrassa
SpainRekrutierend» Google-Maps
Hospital Universitario Miguel Servet
50009 Zaragoza
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA)

status in participants with Stage II (high risk)/III colorectal cancer (CRC) following

resection/prior to adjuvant chemotherapy (AdCTx), during the course of AdCTx and for a period

of 630 days thereafter, according to CRC stages and disease characteristics.

Participants receive no therapeutic intervention as part of this study. This study will

identify participants who might be potential candidates for the clinical trial BNT122-01

(NCT04486378), a study of RO7198457 after completion of standard AdCTx in this patient

population. Based on the eligibility criteria for that trial, this study will identify

participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after

resection and are therefore at high risk of disease recurrence to enrich the BNT122-01 study

cohort. These participants will have the option to enter screening for BNT122-01 at Screening

Visit 2 of that trial if they meet the eligibility criteria of BNT000-001 during screening.

Data from the assessments from BNT000-001 will be carried across to the BNT122-01 trial where

feasible.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Must have given informed consent indicating that they understand the purpose of and

procedures required for the study and are willing to participate in the study.

- Age ≥ 18 years old at time of signing the informed consent form.

- Ability to comply with the study protocol, in the investigator's judgment.

- Must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon

cancer per AJCC 2017 that has been surgically totally resected (R0 confirmed by

pathology report). Stage II (high risk) colon cancer is defined as (any of):

- T4

- Grade ≥ 3

- Clinical presentation with bowel obstruction or perforation

- Histological signs of vascular, lymphatic or perineural invasion

- < 12 nodes examined

- Adequate tumor material in formalin-fixed paraffin embedded (FFPE) blocks or as

sectioned tissue (only upon approval by sponsor) must be available, preferably from

resection. The specimen should be submitted along with an associated pathology report.

Multiple samples may be provided as available, but priority should be given to tissue

with the highest tumor content and lowest necrotic area.

- Intention to receive a standard of care adjuvant chemotherapy (AdCTx) within 8 weeks

post-surgery, and be scheduled for at least 3 months of treatment (including rest

days) according to the treating physician or investigator.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

- Adequate end-organ function.

Exclusion Criteria:

- Induction of neoadjuvant systemic therapy prior to resection of CRC.

- Prior systemic investigational therapy.

- Positive serology for hepatitis B (unless immune due to vaccination or resolved

natural infection or unless passive immunization due to immunoglobulin therapy):

- Positive test for antibodies to hepatitis B core antigens (anti HBc) and

- Negative test for antibodies to hepatitis B surface antigens (anti HBs).

- Active hepatitis C virus (HCV) infection; participants who have completed curative

antiviral treatment with HCV viral load below the limit of quantification by

polymerase chain reaction (PCR) are allowed.

- Participant has a history of human immunodeficiency virus (HIV) antibody positivity,

or tests positive for HIV at screening.

- Residual tumor classification following surgery other than R0 (microscopic

margin-negative resection).

- Participants with known past or current malignancy other than inclusion diagnosis,

except for:

- Cervical carcinoma of Stage 1B or less.

- Non-invasive basal cell or squamous cell skin carcinoma.

- Non-invasive, superficial bladder cancer.

- Prostate cancer with a current PSA level < 0.1 ng/mL.

- Any curable cancer with a complete response (CR) of > 2 years duration.

- Participant has not started standard of care AdCTx within 8 weeks post-surgery.

- Participant has received less than 3 months (including rest days) of AdCTx treatment.

- Inadequate tumor material (either quality or quantity) to support circulating tumor

DNA (ctDNA) analysis.

- Participants who have had prior splenectomy.

Studien-Rationale

Primary outcome:

1. Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample (Time Frame - 4 to 8 weeks after surgery and within 7 days prior up to the day of start of AdCTx):
Blood sample taken post-surgery and pre-adjuvant chemotherapy.

2. Occurrence of ctDNA positivity in the first post-AdCTx blood sample (Time Frame - 14 to 21 days after last AdCTx treatment):
Blood sample taken post-adjuvant chemotherapy.

Secondary outcome:

1. Transfer of participants from the BNT000-001 study to the BNT122-01 clinical trial (Time Frame - 4 weeks following Visit 1 (upon availability of ctDNA positivity status)):
The absolute and relative frequency of participants that will transfer to the BNT122-01 clinical trial from this epidemiological study will be reported.

Geprüfte Regime

  • Regular blood sample collection for ctDNA assessment:
    Blood samples for in vitro testing of ctDNA status will be drawn at study visits every three months

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.