All Drugs and Chemicals

Immunomodulating Agents

Nathan Fowler

Krystle Nomie, PhD

The purpose of this project is to develop a comprehensive database of genomic, transcriptomic, molecular, and clinical characteristics of oncology patients to discover, define, and develop genomic and transcriptomic markers to improve future clinical outcomes across cancer types

Immuno- and targeted therapies have shown promising results for many types of cancer (1). However, the effectiveness of these treatments is not optimal for many patients (2). Therefore, further research is needed to discover, define, and develop genomic, transcriptomic, and integrated molecular markers that can improve clinical outcomes across cancer types (3). Unfortunately, current research is restricted by the limited availability of genomic and transcriptomic results linked to clinical outcomes (3). This study will allow for the collection of key clinical data, including longitudinal follow-up, linked with individual genetic and molecular findings in a single comprehensive registry-based databank. Analysis of these data may lead to advances across cancer subtypes through the identification of transcriptomic and genomic associations with therapies.

Clinical and pathological information, including detailed genetic information from a participant's tumor biopsy, will be obtained by the research staff for each participant enrolled in the BIGR Study. Clinical information will include relevant details about the patient's diagnosis and treatment and will be stored in a secure electronic registry database. No extra scans or procedures for this study will be collected as part of this study. Information will be collected regarding a participant's initial diagnosis, treatment, and outcome. To obtain this information, study staff will contact participants or a participant's doctor at regular time intervals for up to 15 years.

BostonGene-Integrated Genomic Registry (BIGR)

BostonGene-Integrated Genomic Registry Study

associations between genomic findings and outcomes of cancer patients who have undergone comprehensive sequencing.

identify molecular findings associated with therapy.

identify and link registry subjects to future molecular-based clinical research

BostonGene

Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Obesity

Polycystic Ovary Syndrome

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

PCOS women with obesity previously diagnosed with PCOS（meet the 2003 Rotterdam diagnostic criteria） not using hormonal therapy and without other significant health or endocrine issues.

This study enrolled age- and body mass index (BMI)-matched subjects with normal menstrual cycles, not using hormonal therapy, and without any significant health or endocrine issues.

No intervention

Manna Zhang, Ph.D

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in reproductive-aged women， which associated with increased risks to develop metabolic disorders, including cardiovascular diseases, diabetes mellitus, and cerebrovascular diseases. The precise pathogenesis of PCOS remains unknown but is thought to be multifactorial, comprising genetic and environmental factors .

To study the pathogenesis of diseases, the study of multi-omics approach has been applied in various diseases researching . Obesity and PCOS are both metabolic disorders, and both have an impact on metagenomics, metabolomics and transcriptome. Currently, multi-omics studies based on obese PCOS are still limited. Therefore, this study tried to use a multi-omics approach that integrates the gut microbiome, serum metabolomics, serum transcriptomics, and clinical indicators to distinguish obese PCOS from obese non-PCOS women. To investigate whether the specific composition of the gut microbiome is associated with PCOS in obese women. Serum metabolomics and transcriptomics were analyzed to explore potential metabolic pathways. Meanwhile, gut microbiome and serum metabolomics are used to predict the occurrence of PCOS. Then, a new metabolite that could predict PCOS were tested on female mice with high fat diet (HFD).

Metabolome Serum Sample Collection，Transcriptome RNA sample collection and Stool specimen collection

Multi-omics Analysis of Women With PCOS and Obesity Compared With Non-PCOS Obese Controls

Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory to comprehensively analyze non-target metabolites.

Understand phenotypical differences from biological samples comparing women with and without PCOS. Stool samples are to be collected by women and analyzed with metagenomics sequencing.

Understand phenotypical differences from biological samples comparing women with and without PCOS. The researcher will collect and analyze Venipuncture blood for RNA. Differences in the expression of genes between the two groups of subjects, analysis to select possible pathogenic factors leading to the pathogenesis of PCOS.

Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory to comprehensively analyze the target metabolite.

Body mass index (BMI)=weight(kg)/height(m)\^2.

The follicle-stimulating hormone in IU/l.

WHR=(Waist Circumference in centimeters)/(Hip Circumference in centimeters).

the total number of menstrual periods in the last year.

The minimum value of Ferriman-Gallwey score is 0 and the maximum value is 44. An Ferriman-Gallwey score greater than or equal to 6 is considered to be a clinical manifestation of androgen excess.

Homeostatic model assessment insulin resistance index=FBG\*FINS/22.5.

Interleukin 22 in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.

Interleukin 6 in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.

Interleukin 8 in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.

Tumor Necrosis Factor in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.

low-density lipoprotein cholesterol in mmol/L.

high-density lipoprotein cholesterol in mmol/L.

Zhang Manna

Director, Principal Investigator, Clinical Professor

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Pharmaceutical Solutions

A first series of biopsies will be performed during the procedure to place the gold grains prior to radiotherapy. Explants will be performed from these biopsies. Half of these explants will be irradiated with a research irradiator at a dose of 2 Gy then placed for 24 hours in an appropriate culture medium. The other half will be directly cultured for 24 hours. After 24 hours of incubation, half of the irradiated explants and half of the explants will be used to study the transcriptome. The tissues will be stored in RNAlater solution and then frozen at -80°C. The remaining half explants will be used for immunohistochemical analysis. Two years after the end of radiotherapy, a new series of biopsies will be performed for research, in order to verify histologically the effectiveness of radiotherapy.

Before radiotherapy treatment, prostate biopsies will be performed in each patient. From these biopsies, explants will be performed. Half of these explants will be irradiated ex vivo and the other half will not receive any prior treatment.

Then the patient will receive radiotherapy. It will be reviewed 2 years after the end of radiotherapy. New prostate biopsies will be performed to evaluate the tumor response to radiotherapy and to characterize the immunohistochemical and transcriptomic profiles of non-responder patients.

prostate biopsies

Stéphane SUPIOT, MD

Emilie DEBEAUPUIS

STEPHANE SUPIOT, MD

Of the 50,000 prostate cancers that occur each year in France, more than half will benefit from curative radiotherapy, alone or in combination with hormone therapy from 6 months to 3 years depending on the stage of the disease. At present, there are few ways to predict the response to this irradiation.

Evaluating the early response of tumor tissue to irradiation could predict the final response to treatment. It is difficult to offer biopsies during treatment for reasons of patient comfort. This is why this study consists in analysing transcriptomic and protein responses (immunohistochemistry) to irradiation on ex vivo prostate explants. These explants will be irradiated after culture and the transcriptional and immunohistochemical changes analysed before and after irradiation to determine an early tumor tissue response profile to irradiation.

Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers

The centralized anatomopathological study of prostate biopsies will classify patients into good responders (absence of viable tumour cells) and poor responders (persistence of viable tumour cells).

Biological response to radiotherapy the biological response to radiotherapy is assessed by measuring serum PSA levels according to Phoenix criteria, nadir 2 ng/ml

Prostate MRI 2 years after the end of radiotherapy, used to identify the area affected by the tumor

Institut Cancerologie de l'Ouest

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Patients operated for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux

Relapsed glioblastoma

Mathieu LARROQUETTE

Julien ENGELHARDT

Glioblastomas are the most frequent and aggressive malignant tumors of the CNS in adults, with almost systematic relapse despite treatment with surgery followed by radio-chemotherapy (STUPP protocol). The aim of this study is to better characterize transcriptomic, proteomic and metabolic changes in relapsed glioblastoma compared to the initial tumor, in order to identify new prognostic markers and potential new therapeutic targets.

Glioblastomas are the most frequent and aggressive malignant Central Nervous System (CNS) tumors in adults, with a median survival of only 14 months.

Current treatment is based on surgery followed by radiochemotherapy (STUPP protocol), unchanged since 2005. Clinical trials evaluating immune checkpoint inhibitors and targeted therapies have largely failed to demonstrate efficacy in these tumors. In order to better understand the oncogenesis of glioblastoma and identify potential new therapeutic targets, the study of the characteristics of relapsed tumors compared with the initial tumor seems relevant.

The aim of this retrospective study is to investigate the transcriptomic, proteomic and metabolic characteristics of relapsed glioblastomas reoperated at the University Hospital of Bordeaux, France, between 2005 and 2023, for which tumor material is available. These analyses will be correlated with relapse-free and overall survival of the patients.

Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma

Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.

Relative abondance of metabolite and differential enzyme expression in a recurrence versus primary sample

Progression-free survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse measured at time of inclusion

Overall survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BostonGene-Integrated Genomic Registry (BIGR)	NCT04991922	Malignancy		18 Years -	BostonGene
Multi-omics Analysis of Women With PCOS and Obesity Compared With Non-PCOS Obese Controls	NCT05468476	Polycystic Ovar...	No intervention	18 Years - 45 Years	Shanghai 10th People's Hospital
Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers	NCT03961737	Prostate Cancer	prostate biopsi...	18 Years -	Institut Cancerologie de l'Ouest
BostonGene-Integrated Genomic Registry (BIGR)	NCT04991922	Malignancy		18 Years -	BostonGene
Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma	NCT06430424	Relapsed Cancer Glioblastoma ID...	Relapsed gliobl...	18 Years -	University Hospital, Bordeaux
Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma	NCT06430424	Relapsed Cancer Glioblastoma ID...	Relapsed gliobl...	18 Years -	University Hospital, Bordeaux

Spots Global Cancer Trial Database for transcriptomic