SYF08699aa285fc485b8ca8fbba60bc8d36Registry ID: 2023-504943-15-00|RecruitingPhase 2
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interventional
N/A
1 country
3
To assess whether treatment with Tofranil© produces significant changes in the histological and molecular manifestations of the epithelial-mesenchymal transition (EMT) in the period from tumor diagnosis by biopsy to surgical resection. The evaluation of the Main Objective will be carried out in the histological examination of the tumor piece product of the surgical resection; usually at 2-6 weeks for group A and between 3-6 months for neoadjuvant patients (group B).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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July 31, 2023
Actual (reported)Changes in the invading front associated with the epithelial-mesenchymal transition quantified as measurement of tumor budding, cytoplasmic pseudofragments, pattern of tumor invasion, and characteristics of the immune infiltrate (intra- and peritumoral lymphocytes, characterization of Crohn-like response macrophages).
Evaluation of plasma quantification of tumor DNA copies and the expression of serum and tissue fascina1 in the surgical resection piece.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
TOFRANIL 50 mg comprimidos recubiertos
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
TOFRANIL 50 mg comprimidos recubiertos
Named ingredient: Imipramine hydrochloride
View registry recordUniversity Clinical Hospital Virgen De La Arrixaca
Murcia, 30120, Spain
General University Hospital Santa Lucia
Cartagena, 30202, Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008, Spain
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First Submitted
July 31, 2023
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