2023-504943-15-00RecruitingPhase 2
HIsTological and CLinical effects of Imipramine in the treatment of patients with cancer over-expressing Fascin1. (HITCLIF)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 31 Jul 2023
- Start date
- 19 Aug 2022
- Lead sponsor
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Diseases
- Colorectal cancer
- EU CT number
- 2023-504943-15-00
- EudraCT number
- 2021-001328-17
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colon, rectal or triple negative breast cancer that can be removed by surgery and has too much Fascin1.
- Age
- Over 18 years
- Sex
- All sexes
- Disease stage
- Colon, rectal or triple negative breast cancer, confirmed by biopsy. The tumor can be removed by surgery. No spread to other parts of the body at diagnosis.
- Earlier treatment
- Cannot be taking SSRIs, SNRIs, MAOIs, tramadol or trazadone now or in the 14 days before joining.
- Biomarker or test result
- Overexpression of fascina1 in the primary tumor.
Main reasons for not taking part
- Spread of the cancer (metastatic disease) at diagnosis
- Colorectal cancer with signs of a blocked or nearly blocked bowel
- Known major depressive disorder, bipolar depression or psychosis
- ECOG scale 3 or 4
- History of heart disease
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient on current treatment with SSRIs, SNRIs, MAOIs, tramadol or trazadone or within the 14 days prior to recruitment.
Other illness
- Metastatic disease at diagnosis or not candidates for neoadjuvant therapy.
- Colorectal cancer with clinical symptoms of sub-obstruction or obstruction.
- Known diagnosis of major depressive disorder, bipolar depression, or psychosis.
- Suspected inability to comply with treatment adequately or conditions that limit its reliability (psychiatric illness, drug addiction, etc.).
- History of heart disease.
Lab values
- Severe renal failure (GFR <30 mL/min).
- Hepatic failure or bilirubin > 2 mg/dl.
Age
- Woman of childbearing age who refuses to use any contraceptive method.
Other
- ECOG scale 3 or 4.
Who the study is looking for
- Resectable tumor.
- Obtaining Written Informed Consent.
- Diagnosis of colon, rectal or triple negative breast cancer by biopsy.
- Overexpression of fascina1 in primary tumor.
- Patient over 18 years of age
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General University Hospital Santa Lucia | Cartagena | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Recruiting |
| Hospital General Universitario Morales Meseguer | Murcia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.