Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Gut microbiota analysis from diagnosis to follow up after first line-chemo-immuntherapy

Gut microbiota samples

Pier Luigi L Zinzani, Professor

In Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not. Approximately 40% of DLBCL patients has refractory disease or will relapse after initial response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation in response to chemotherapy, has been suggested. In this scenario, the Investigators hypothesized that GM could play an important role in DLBCL prognosis and response to treatment, establishing a connection between lifestyle and clinical response. The project is aimed to the study of the functional GM layout in association with specific patterns of treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy. Results may build the scientific basis to design new and personalized intervention strategies (both in treatment approach and in life-style recommendations), to enhance clinical response and reduction of disease refractoriness through modulation of the gut microbial ecosystem.

Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma

* dysbiosis index: the dysbiosis index relies on the calculation of the weighted ratio between health-promoting and disease-associated GM components
* relative abundance of GM biomarkers of an eubiotic GM state: all GM dysbiotic states share a common feature, i.e. the depletion of strategic health-promoting GM components such as Faecalibacterium prausnitzii and Lachnospiraceae. Thus, a GM dysbiotic state is determined by the assessment of a reduction of the abundance of these GM biomarkers below the thresholds characteristic of an eubiotc GM state.

Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET negative and all lymph nodes and nodal masses must have regressed on CT to normal size ( 1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy).

University of Bologna

Full Professor, MD (Hematologist)

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

Immunomodulating Agents

20 breast cancer patients who performed radiotherapy treatment

maximum 10 patients who performed radiotherapy and chemotherapy and/or immunotherapy and/or neo-adjuvant hormone therapy or/and adjuvant immunotherapy/hormone therapy.

healthy women with +/- 5 years compared to breast cancer patients age

blood samples collection are performed at 4 different timepoints: preop, pre rt, week 6 rt, week 12-14 (fu) for GROUP I and GROUP II; blood samples collection are performed at 3 different timepoints: pre rt, week 6 rt, week 12-14 (fu) for GROUP I bis; blood samples collection are performed just once for control GROUP.

blood samples collection

Alessandra Franzetti Pellanda, MD

Radiation applied to the preserved breast during radiotherapy treatment activates numerous molecular cascades in tumor bed adjacent cells causing an inflammatory state. During this process, pre-clinical studies demonstrated CD11b + and CD11b+cKit+cells mobilization in the blood. These cells are involved in numerous processes during tumor progression/control and metastases development. The expected results in clinical setting allow us to investigate the development of innovative therapeutic and monitoring strategies. The clinical repercussions would consist in identifying new predictive and prognostic targets in breast cancer.

Every year, around one million women are newly diagnosed with breast cancer. Early screening and adjuvant treatments with curative intent such as radiotherapy, hormone therapy, chemotherapy, immunotherapy, have reduced the incidence of breast cancer specific mortality. Despite this, breast cancer remains the main cause of cancer mortality in Europe. The primary cause is due to metastases development in different organs, such as lung, liver, bones and brain. A significant decrease in mortality in breast cancer patients is likely to be achieved by preventing the formation of metastases or by implementing the efficacy of their treatment. Radiotherapy is one of the pillars of breast cancer adjuvant treatments with important survival benefits.

Mutual and dynamic communications between tumor cells and the tumor microenvironment (TME) influence the development and evolution of the tumor as well as the appearance of distant metastases. The mediators of the immune and inflammatory response that constitute TME, as well as mediators of tumor progression, are also considered "targets" of future therapeutic strategies.

Radiation applied to the preserved breast during radiotherapy treatment activates numerous molecular cascades in tumor bed adjacent cells causing an inflammatory state. During this process, pre-clinical studies demonstrated CD11b + and CD11b+cKit+cells mobilization in the blood. These cells are involved in numerous processes during tumor progression/control and metastases development. The results allow us to investigate the development of innovative therapeutic and monitoring strategies. The clinical repercussions would consist in identifying new predictive and prognostic targets in breast cancer.

Adjuvant Radiotherapy on Circulating Cells in Breast Cancer Patients

Effects of Adjuvant Radiotherapy on Bone-marrow Derived and Immune Cells in Breast Cancer Patients

validate the hypothesis that adjuvant radiotherapy in breast cancer modulates the frequency of CD11b⁺cKit⁺ cells in peripheral blood and / or gene expression in circulating CD11b⁺ cells, evaluating their trend at different time points compared to radiotherapy treatment.

validate the hypothesis that adjuvant radiotherapy alters in a potentially predictive way the frequency of CD11b⁺cKit⁺ cells in peripheral blood and / or gene expression in circulating CD11b⁺ cells.

Curzio Rüegg, MD, Head of Department, University of Fribourg

Swiss National Science Foundation

Tsoutsou Pelagia MD, Head of Radation Therapy Department

Clinica Luganese Moncucco

Head of Radiation Therapy

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.

The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.

Photon

Proton

Same dose and fractionation will be used in both arms.

Carbon ion

Lin Kong, MD

Jiyi Hu, MD

Jiade J Lu, MD

Jiade Lu, MD

The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.

The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent \[GyE\]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.

Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma

Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.

CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment.

Acute and late toxicities induced by radiation therapy other than xerostomia.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma	NCT03797170	Diffuse Large B...	Gut microbiota ...	18 Years -	University of Bologna
Adjuvant Radiotherapy on Circulating Cells in Breast Cancer Patients	NCT04002570	Breast Cancer	blood samples c...	18 Years - 75 Years	Clinica Luganese Moncucco
Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma	NCT04528394	Nasopharyngeal ...	Photon Proton Carbon ion	18 Years - 70 Years	Shanghai Proton and Heavy Ion Center
Adjuvant Radiotherapy on Circulating Cells in Breast Cancer Patients	NCT04002570	Breast Cancer	blood samples c...	18 Years - 75 Years	Clinica Luganese Moncucco

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