NCT06642506Active, not recruiting
Oncometabolome and MALDI-MSI in Upper GI Carcinomas - Chemosensitivity in Esophageal Carcinoma
Oncometabolome and MALDI-MSI in Upper GI Carcinomas - Chemosensitivity in Esophageal Carcinoma.
Source: ClinicalTrials.gov · Last updated 12 Nov 2024
Brief summary (registry, in English)
Locally advanced adenocarcinoma of the esophagus is a leading cause of death from malignant disease in Germany and has been characterized on a molecular level in recent years. This retrospective observational study deals with patients after esophagectomy with different risk constellations of esophageal carcinoma. An early and individualized therapy of this tumor in an approach of precision oncology significantly improves the prognosis. The metabolomic profile plays a central role in tumor plasticity and oncological outcome. At the same time, these factors affect the efficacy of chemotherapy and need to be investigated in more detail at the molecular level. A central element of this study is the investigation of phospholipid metabolism locally in tumor tissue, in adjacent normal tissue in terms of the tumor microenvironment and systemically in blood plasma. The focus lies on the validation of known oncometabolites that significantly influence tumor sensitivity to chemotherapy. By combining mass spectrometry imaging using matrix-assisted laser desorption ionization - mass spectrometry imaging (MALDI-MSI) with metabolomics using liquid chromatography tandem mass spectrometry (LC-MS/MS), the metabolic profile of tumors can be analyzed in detail, allowing conclusions to be drawn about chemo-insensitive and therapeutically challenging tumors. Both mass spectrometric methods are used to understand the heterogeneous metabolism of the tumors and to describe possible constellations that are associated with increasing chemoresistance. For precise investigation, the cohort under investigation is divided into two patient collectives. Patients with a regression grade 1 after four sessions of FLOT chemotherapy are compared with a regression grade 3 according to Becker in the postoperative pathological assessment. This facilitates the development of personalized therapeutic approaches tailored to the individual oncological profiles of the tumors. The study is complemented by conventional HE microscopic examinations of the tumor itself and the tumor microenvironment, which allow to analyze the morphology and its correlation with metabolic alterations in the tissue. We hypothesize that adenocarcinoma of the esophagus with regression grade 1 encompasses a fundamentally distinct metabolic profile than adenocarcinoma of the esophagus with regression grade 3. Consequently, a stratification parameter within the local tumor metabolism and the tumor microenvironment exists, which correlates with the systemic response to neoadjuvant chemotherapy in blood plasma. The primary aim of the study is to create a comprehensive metabolic profile that clearly identifies tumors with a regression grade 1 versus a regression grade 3 according to Becker. This will be used to improve diagnostics and develop personalized treatment strategies that increase treatment efficiency and patients' chances of survival. This is ultimately carried out with the intention of achieving an improved survival rate and a higher quality of life for patients with locally advanced esophageal cancer. The comprehensive analysis of the tumor microenvironment and the morphological and metabolic profiles should provide new insights into the mechanisms of tumor progression and resistance, which in turn will form the basis for future translational research and treatment approaches. The findings from this study have the potential to change the way esophageal cancer is treated by contributing to the development of stratified therapeutic approaches tailored to the molecular subtype of esophageal cancer.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 20 (actual)
- First submitted
- 11 Oct 2024
- Start date
- 6 Oct 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- NCT number
- NCT06642506
What you commit to
- Study type: Observational
- Participants enrolled: 20
- From 6 Oct 2024 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with chemotherapy, targeted therapy or radiotherapy for treatment of advanced cancer disease less than 5 years.
- Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. ∙
- Prisoners or study participants who are involuntarily incarcerated
- Pregnancy or breastfeeding females
- ∙ Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy.
Other illness
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Any chronic skin condition that does not require systemic therapy
- Patients with celiac disease controlled by diet alone.
- Inhaled or topical steroids and adrenal replacement steroid doses \>10mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
- History of active primary immunodeficiency
- History of any allogenic organ transplantation with currently intake of immune suppressive treatment
- Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity. FEV 1 \< 75%
- Patients has known current symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Lab values
- Any other serious or uncontrolled medical disorder, active infections, physical exam findings, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a study participant's ability to comply with the study requirements, substantially increase risk to the study participant, or impact the interpretability or study results
Other
- Study participants with squamous cell carcinoma of the esophagus
- Enrollment is possible for patients with:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism stable on hormone replacement
Who the study is looking for
- Signed Written Informed Consent
- Study participants must have signed and dated an IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
- Study participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
- Histologically confirmed, resectable adenocarcinoma of the esophagus (uT2, uN+, cM0 or uT3, cNx, cM0), with the following specifications:
- Medical and technical operability
- No preceding cytotoxic or targeted therapy
- No prior partial or complete tumor resection
- Male or female patients \> 18 years of age at time of study entry
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Life expectancy of at least 12 months
- Adequate normal organ function as defined below. Screening laboratory values must meet the following criteria and should be obtained within 28 days prior to registration
- WBC ≥ 1500/μL
- Neutrophils ≥ 1000/μL
- Platelets ≥ 75 x103/μL
- Hemoglobin \> 9.0 g/dL
- Serum creatinine ≤ 1.5 x institutional ULN or calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault)
- AST/ALT ≤ 2,5 x institutional ULN
- Total Bilirubin ≤ 1.5 x institutional ULN
- Body weight \> 30kg
- Reproductive Status
- Women of childbearing potential must have a negative serum or urine pregnancy test within one until two weeks prior to the start of neoadjuvant treatment and after surgery before starting adjuvant treatment.
- Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago.
- Women must not be breastfeeding.
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of General, Visceral and Transplantation Surgery, LMU University Hospital Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.