Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

resectable tumor receiving a curative intent treatment.

unresectable tumor treated with palliative chemotherapy

Aziz Zaanan, MD, PhD

Pierre Laurent-Puig, MD, PhD

Julien Taieb, MD, PhD

Jean-baptiste Bachet, MD, PhD

The evaluation of the chemotherapy efficacy for gastric cancer patients is usually evaluated by computer tomography scans with RECIST criteria that are performed every two months during the treatment. The management of treatment for gastric cancer needs the development of early biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early chemotherapy resistance. In this prospective study, we will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9 tumor markers.

Thus, the objective of this study is to identify a prognostic and/or predictive biomarker of tumor response according to the tumor DNA circulating assessment in gastric cancer treatment, in order (i) to avoid an unnecessary toxicity of an ineffective treatment that it would be continued uselessly, (ii) and to allow a early changing to an alternative chemotherapy regimen.

Introduction The cell lysis phenomena tumor releases DNA that can be detected in the blood and in other biological fluids such as lymph, urine or stool. An increase in plasma levels of tumor DNA is described in patients with cancer, and recently, monitoring of circulating tumor DNA that has been proposed as a relevant potential marker to assess the prognosis and the early response to treatment of colon or breast cancers (Dawson et al, 2013; Spindler et al, 2013; Tie et al, 2015). However, there is no data on the prognostic and predictive impact of circulating tumor DNA in context of gastric cancer treatment.

The aim of this study is to evaluate the correlation between the level of circulating tumor DNA and prognosis or response to treatment of localized and advanced gastric cancer.

Patients and Methods:

Three university hospitals of "Assistance Publique Hôpitaux de Paris" (AP-HP) will participate in this prospective study: European Georges Pompidou hospital, Pitié-Salpêtrière hospital and Cochin hospital. Inclusion criteria were all patients aged over 18 years with localized or advanced adenocarcinoma of gastric or gastro-oesophageal junction, histologically proven. The patients will be enrolled over a period of 2 years after receiving and signed a specific consent information form.

This is a non-interventional study who does not change the management of patients. There will be no additional invasive procedures to those already scheduled for routine care. Blood samples will be made at the time of chemotherapy sessions from the Huber needle previously implanted in the port-a-cath for the administration of chemotherapy agents.

The circulating tumor DNA is analyzed and quantified by sequencing proton from somatic genetic alterations identified in the tumor (Inserm Unit 775 UMR_S, Professor Pierre Laurent-Puig).

The data related to the patient (age at diagnosis, sex, weight, height, WHO performance status), tumor (tumor markers CEA and CA 19-9, date of diagnosis of gastric cancer, histological type and tumor differentiation, tumor stage, and metastatic sites) and treatment (resection of the primary tumor, date of surgery, chemotherapy protocol) will be collected anonymously. Monitoring data concern the efficacy of chemotherapy (tumor response, the date of disease progression, survival), as well as the possible dates of tumor recurrence or death.

The Statistical analysis will be based on a survival model in order to predict the responder or non-responder status, including parameters normally associated with risk of recurrence and death. The association between changing in circulating tumor DNA levels in responders and non-responders will be performed with a Cox model; the DNA circulating levels will be considered as a variable dependent of time. An estimation of 100 patients is planned for each cohort (localized and advanced diseases) with a recruitment period of approximately 2 years.

Expected Results

* For the cohort of patients with a localized tumor: loss (or decrease) in circulating tumor DNA after curative treatment for patients who do not exhibit tumor recurrence; OR no loss (or increase) in circulating tumor DNA after curative treatment in patients with tumor recurrence.
* For the cohort of patients with advanced tumor: early and significant increase in the level of circulating tumor DNA in non-responders to chemotherapy; OR early and significant reduction in the level of circulating tumor DNA in patients who respond to the treatment.

Prognostic and Predictive Impact of Circulating Tumor DNA in Gastric Cancer Treatment

Prognostic and Predictive Impact of Circulating Tumor DNA in Advanced and Localized Gastric Cancer Treatment

PFS will be evaluated according to the circulating tumor DNA

Tumor response rate will be evaluated according to the circulating tumor DNA

OS will be evaluated according to the circulating tumor DNA

Association des Gastroentérologues Oncologues

MD, PhD

Musculoskeletal Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Immune System Diseases

Arthritis

Necrosis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Analgesics

Gastrointestinal Agents

Antiemetics

Neuroprotective Agents

Micronutrients

Hematinics

Vitamins

Methotrexate

Prednisone

Prednisolone

Glucocorticoids

Etanercept

Adalimumab

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Anti-Inflammatory Agents, Non-Steroidal

Infliximab

Leflunomide

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Protective Agents

Tumor Necrosis Factor Inhibitors

Analgesics, Non-Narcotic

Folinic Acid

Folate

Vitamin B9

Infliximab plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.

Etanercept plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.

Adalimumab plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.

Methotrexate will be received orally with dosage of 10mg/ week for every patient and MTX dose must be stable for at least 4 weeks.

methotrexate(necessary)

infliximab :intravenous injection 200mg,every times,0,2,6,14week ,4 times)

infliximab

Etanercept :hypodermic injection,25mg/twice a week

etanercept

Adalimumab:hypodermic injection,40mg/twice a week

adalimumab

LEF will be permitted if patient had received for 1 month before enrollment and will not be changed for 14 weeks.

leflunomide (permitted, not necessary)

NSAIDs will be allowed if patient had received for 1 month before enrollment and will not be changed for 14 weeks.

NSAIDs (permitted,not necessary)

Glucocorticoids (prednisone less than 10mg/day, or equal dosage of other similar drugs) will be permitted if the patient had received for 1 month before enrollment and the dosage will not be changed during the period.

Glucocorticoids (permitted,not necessary)

Fen Li, doctor

Rheumatoid arthritis (RA) is a chronic and disabling disease. tumor necrosis factor-a(TNF-a) inhibitors have demonstrated an outstanding performance in relieving joint inflammation and retarding bone erosion involved in RA. However, there is still about one-thirds of RA patients had a poor response to TNF α inhibitors. The Investigators hope to discover prediction protein with a domestic genetic background and finally establish prediction system with Chinese characteristics.

Rheumatoid arthritis (RA) is a chronic and disabling disease. TNF-α inhibitors have demonstrated an outstanding performance in relieving joint inflammation and retarding bone erosion involved in RA. However, there is still about one-thirds of RA patients had a poor response to TNF α inhibitors. Currently the personalized biological treatment is the research hotspot. Recent studies focuses on exploring biomarkers predictive of drug response. The research methods such as genomics, transcriptomics, proteomics, metabolomics and immunocytology, have been applied,but they are not successfully integrated. The related studies in China are still at an initial stage, which necessitates an in-depth study in this area. The investigators' preliminary study showed that TNF-α-308 gene polymorphisms existed in Chinese RA patients and phosphoinositide 3-kinase/Akt signal pathway was activated in proliferated synovial fibroblasts stimulated by TNF-α. Therefore, for the first attempt in China, the investigators intend to screen for differential proteins by using isobaric tags for relative and absolute quantitation(iTRAQ) technique in RA patients receiving anti-TNF-α therapy, and then verify the predictive effects of selected differential proteins from the upstream gene polymorphism to the downstream protein expression. The investigators will also explore the mechanisms of differential proteins involved in TNF-α related signal pathway by using in vitro gene transfer, siRNA interference, and RA animal models. Through this study investigator hope to discover some prediction proteins with a domestic genetic background and finally establish a prediction system with Chinese characteristics.

Predictability Studies on the Efficacy of TNF-α Inhibitors in Chinese RA From "Real World"

Screening Protein Predictive of Response to Tumor Necrosis Factor-α Inhibitors Treatment in Chinese Rheumatoid Arthritis From "Real World" and Investigating Its Mechanism Through Signal Pathway

EULAR (European League Against Rheumatism) response is based on changes of DAS28-CRP. The following good, moderate and no response are defined based on changes of DAS28-CRP from baseline to weeks 14: \>1.2 units are good response; 0.6-1.2 units are moderate response; ≤0.6 units are no response.

The DAS28-CRP will be calculated at every visit within the clinical database. The components of the DAS28-CRP score assessment are: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement will be made at baseline and weeks 14.

The TNF level assessment is a direct measurement using ELISA by testing patients' serum. This measurement will be made at baseline and weeks 14.

The classification of EULAR response and the calculation of DAS28-CRP are based on above of Primary Outcome Measure.

Interest proteins will be screened by iTRAQ (isobaric tags for relative and absolute quantitation). This measurement will be made at baseline and weeks 14 by comparing part of patients with good response or no response.

Interest proteins being screened will be verified by Western Blot among all patients of 3 groups.

The classification of EULAR response and the calculation of DAS28-CRP are based on above of Primary Outcome Measure.

SNP of TNF gene will be tested by PCR-RFLP (Polymerase Chain Reaction -Restriction Fragment Length Polymorphism). This measurement will be made at weeks 14 among all 3 groups' patients.

The classification of EULAR response and the calculation of DAS28-CRP are based on above of Primary Outcome Measure.

SNP of gene about interest proteins will tested by PCR-HRM(Polymerase Chain Reaction-high resolution melting). This measurement will be made at weeks 14 among all 3 groups' patients.

Interest proteins are screened and verified on above of Secondary Outcome Measure.

The classification of EULAR response and the calculation of DAS28-CRP are based on above of Primary Outcome Measure.

Fen Li

associate chief physician

Neoplastic Cells, Circulating

Neoplasms, Unknown Primary

Neoplasm Metastasis

Neoplastic Processes

Subjects referred, based on standardised criteria, for investigation and diagnosis for possible cancer of unknown primary (CUP).

Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

Subjects referred, based on standardised criteria, for investigation and diagnosis for suspected cancer (SCAN) based on serious non-specific symptoms and signs of cancer.

Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

Patient stratification based on presence or absence of suspicious findings of cells and DNA

Circulating tumor cell and circulating tumor DNA test

Roland Soderholm, MD

Charlotta Savblom, MD, PhD

Christer Ericsson, PhD

Patients with suspected cancer (SCAN) and cancer of unknown primary tumor (CUP) are vulnerable because the investigation is difficult and expensive and have poor prognosis because few effective established curative treatments are available. Great progress has been made, for example through highly qualified and systematic clinical investigations not least within the framework of the standardized care processes. However, there is a need for faster, less invasive and more cost-effective tests to confirm or exclude the diagnosis of carcinoma (epithelial cancer), primarily for SCAN and secondly for CUP, and partly to receive suggestions for localization of the primary tumor for primarily CUP and secondly SCAN. There is also a need for prediction of molecularly targeted therapies.

New research provides opportunities for using a blood test to acquire detailed and updated information about the individual patient's disease and thus also open new opportunities for faster, less invasive and more cost-effective diagnosis and prediction of molecularly targeted treatments based on individualized sampling and molecular stratification. It is important that these opportunities are tested in a timely fashion in practical health care, so the new opportunities can be taken advantage of and developed in the best way. The aim is to establish a new "best practice" for these hard-to-study and difficult-to-treat patients.

Samples will be taken of epithelial cells circulating in the blood, and of the free circulating DNA.

As a reference, germ-line DNA will also be sampled, also from regular blood samples.

The analyses will show whether the cellular and molecular tests can work in the existing standardized care processes for SCAN and CUP, or if adaptations in routines, training or equipment need to be introduced.

The analyses will also give an indication of whether the cellular and molecular sample analyses provide practically useful information for confirming or refuting the diagnosis of cancer, suggesting from which organ the cancer originated and for predicting individualized therapies, and whether adaptations in routines, training or technology need to be introduced.

Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP

The Value of Molecular Biological Analysis of Blood Samples in Standardized Care Procedures in Suspected Cancer (SCAN) and Cancer of Unknown Primary (CUP)

There is no plan to make individual participant data (IPD) available to other researchers

Can blood samples be taken, processed in a timely manner and processed for isolation and analysis of circulating epithelial cells and free circulating DNA within the framework of the standardized care process for SCAN and CUP?

Are the cellular and molecular sample analyses already practically useful for the universal confirmation or exclusion of the diagnosis of epithelial cancer, suggest from which anatomic location the cancer originated and predict individualised treatment, or should the test be re-focused on certain areas of diagnosis, or developed technically, in order to assist the diagnostic investigation and predict the treatment based on detailed information of the current state of the individual patient's disease?

Karolinska Institutet

iCellate Medical

Christer Ericsson

Senior scientist

Gland and Hormone Related Diseases

Adenocarcinoma

Pancreatic Neoplasms

Pancreatic Cancer

Gemcitabine

Paclitaxel

Fluorouracil

Albumin-Bound Paclitaxel

Folfirinox

Tubulin Modulators

Antimitotic Agents

All patients with periampullary adenocarcinoma or pancreatic cancer receiving palliative or adjuvant chemotherapy (e.g. Gemcitabine, Folfirinox, etc.) in the Department of Oncology, Skåne University hospital, Malmö and Lund

Adjuvant or palliative chemotherapy according to national guidelines

Karin Jirström, Professor

Sofie Olsson Hau, MD

Karin Leandersson, Professor

Margareta Heby, MD

The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that started Sept 1 2018. Patients diagnosed with pancreatic or other periampullary adenocarcinoma undergoing adjuvant och palliative chemotherapy are invited to participate. The study will examine the tumors' molecular dynamics and how this may change over time and with treatment. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life. We estimate that 90 patients will be included in the study per year.

The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that will start Sept 1 2018. All patients diagnosed with a histologically or cytologically confirmed diagnosis of pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, Malmö will be invited to participate. The estimated number of recruited patients is 90/year, 75 with pancreatic cancers. Of note tumour origin can seldom be firmly established in non-resectable cases, where only a fine needle aspiration or biopsy specimen is available before initiation of palliative chemotherapy. Main exclusion criteria are: 1. patients having another concomitant life-threatening disease and 2. patients who are unable to receive chemotherapy will be informed about the study by their oncologist and a research nurse and, if they want to participate, will sign an informed consent form.

The treatment regimen will follow national guidelines, and will not be affected by the study. Clinical and pathological data will be compiled at study entry. Radiological and clinical workup will be performed every three months. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life (EORTC-QLQ-PAN26). Serial sampling of blood during chemotherapy treatment will be performed by a dedicated research nurse along with the clinical routine sampling. Plasma and serum samples for analysis of ctDNA and cytokines, respectively, will be will be drawn before chemotherapy start (timepoint 0/T0), and prior to each additional course of chemotherapy (monthly e.g. gemcitabine based regimens; T1-5 or biweekly e.g. combination regimen FOLFIRINOX; T1-11), and after the last course of treatment (T6 or T12). Peripheral blood mononuclear cells (PBMC) will be isolated from buffy coat in plasma vials before start of chemotherapy (T0), before the second or third (T2/T3) (monthly or biweekly, respectively) course of chemotherapy, before the fourth or seventh (T4/T7) course of chemotherapy, and after the last course of treatment. A homepage is under construction.

Plasma samples (for circulating tumor DNA) and serum samples (for cytokines) Tumor cytology and/or tumor biopsy for biomarkers and mutations.

Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer

Lund University

Cholangiocarcinoma

Biliary Tract Neoplasms

Biliary Tract Diseases

Bile Duct Cancer

Biliary Tract Cancer

Cindy Neuzillet, Dr

Marie-Line Garcia, Dr

Vincent HAUTEFEUILLE, MD

Carole VITELLIUS, MD

Angélique VIENOT, MD

Jean Charles NAULT, MD

Christophe TOURNIGAND, MD

Sylvain MANFREDI, MD

Gaël ROTH, MD

Anthony TURPIN, MD

Mathieu SARABI, MD

Marielle GUILLET, MD

Thomas WALTER, MD

Pascal ARTRU, MD

Brice CHANEZ, MD

Eric ASSENAT, MD

Yann TOUCHEFEU, MD

Ludovic EVESQUE, MD

Jean Paul LAGASSE, MD

Jean Baptiste BACHET, MD

Aude GUILLEMIN, MD

Romain CORIAT, MD

Raphaël COLLE, MD

Nelson LOURENCO, MD

Christophe LOUVET, MD

Jean François BLANC, MD

David TOUGERON, MD

Alexandra HEURGUE, MD

Julien EDELINE, MD

Lilian SCHWARZ, MD

Cindy NEUZILLET, MD

Nicolas WILLET, MD

Nadim FARES, MD

Thierry LECOMTE, MD

Marie MULLER, MD

Antoine HOLLEBECQUE, MD

The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy, targeted therapy,loco-regional treatments ) in patients with bile duct cancer. The effectiveness and tolerance of these treatments in current practice will also be evaluated.

Bile duct cancers are a heterogeneous group of rare tumors with a poor prognosis. Surgery is the only curative modality for localized forms. Chemotherapy is the standard treatment in advanced forms. Identification of prognostic and predictive markers to better stratify patients and to guide therapeutic decisions is a major issue. It is retro-prospective (diagnosis between 2003 and 2021) and prospective (diagnosis between 2021 and 2030) multi-center, cohort study. Follow-up for 10 years from initial cancer diagnosis will be done.

Follow-up is retrospective only for patients operated on or diagnosed in the past for more than 10 years, and retro-prospective for operated patients or diagnosed in the past for less than 10 years.

The data collected for each patient are available during the life cycle of this clinical trial to fulfil an educational requirement (e.g. a doctoral thesis) upon request and authorization from the study committee and the study sponsor (GERCOR).

Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study

Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL

Identification of clinical and tumor predictive factors of overall survival (OS) (prognostic markers) in patients with advanced bile duct cancer (BDC).

OS defined as a period between the start of treatment and death, whatever the cause.

Identification of clinical and tumor predictive factors of overall survival (OS) (prognostic markers) in patients with bile localized BDC (operated).

OS defined as a period between the start of treatment and death, whatever the cause.

Assessment of treatments effects on the response rate (RECIST v 1.1, Choi).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prognostic and Predictive Impact of Circulating Tumor DNA in Gastric Cancer Treatment	NCT02674373	Gastric Cancer		18 Years -	Association des Gastroentérologues Oncologues
Predictability Studies on the Efficacy of TNF-α Inhibitors in Chinese RA From "Real World"	NCT02878161	Rheumatoid Arth...	methotrexate(ne... infliximab etanercept adalimumab leflunomide (pe... NSAIDs (permitt... Glucocorticoids...	18 Years - 75 Years	Central South University
Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP	NCT04025970	Neoplasms, Unkn... Cancer	Circulating tum...	18 Years - 125 Years	Region Stockholm
Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer	NCT03724994	Periampullary A... Periampullary C... Pancreatic Canc...	Gemcitabine	18 Years -	Lund University
Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study	NCT04935853	Biliary Tract C...		18 Years -	GERCOR - Multidisciplinary Oncology Cooperative Group
Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP	NCT04025970	Neoplasms, Unkn... Cancer	Circulating tum...	18 Years - 125 Years	Region Stockholm

Spots Global Cancer Trial Database for predictive

Every month we try and update this database with for predictive cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for predictive

Every month we try and update this database with for predictive cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for predictive cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.