Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients

Launched by HOSPICES CIVILS DE LYON · Dec 20, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a substance called progastrin, which is usually not found in healthy people's blood but can be released in higher amounts in patients with various types of cancer. Researchers want to see if measuring progastrin levels at the time of diagnosis and during treatment can help in diagnosing cancer and predicting how well treatment might work. The trial includes patients with different types of cancer, such as breast, lung, colorectal, and pancreatic cancer, among others.

To participate, patients must be at least 18 years old and have a confirmed diagnosis of one of the eligible cancers. They should have plans for treatment, whether aiming for a cure or managing the disease without a cure. Participants will be closely monitored, and their progastrin levels will be measured throughout the trial. This study is important because it might reveal new ways to understand cancer better and improve treatment strategies for patients.

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Eligibility criteria

• * Histologically and/or cytologically documented (documentation obtained before or after diagnostic surgical procedure when clinical suspicion is strong), cancers for the following cohorts:
• • o Breast carcinomas
• • o Gastric carcinomas
• • o Renal carcinomas
• • o Prostate carcinomas
• • o Lung carcinomas: NSCLC and SCLC
• • o Hepatocellular carcinomas
• • o Colorectal carcinomas
• • Head and neck carcinomas
• • Thyroid cancer
• • Pancreatic carcinomas
• • Ovarian adenocarcinomas
• • Glioblastoma
• • Endometrial adenocarcinomas
• • Bladder carcinoma
• • Superficial Oesophago-gastric carcinomas
• • Diffuse Large B-cell Lymphomas
• • Patient older than 18 years.
• • Patients who gave its written informed consent to participate to the study
• • Patients affiliated to a social insurance regime
• Specific inclusion criteria for curative treatment strategy cancer patients:
• • Indication of a treatment strategy with curative intent (surgery; radiotherapy; chemotherapy; hormonotherapy; targeted agents...)
• • Patient naïve of anticancer treatments for the considered cancer
• • A prior anti-cancer treatment is allowed if this treatment was performed with curative intent, and if it did not include systemic chemotherapy, and if a complete remission ≥ 6 months was observed in between the end of treatment and relapse. Previous local treatments for superficial lesions are allowed without any time restriction (for example among others, intravesical treatment for superficial bladder cancer lesions).
• Specific inclusion criteria for non-curative treatment strategy cancer patients:
• • Indication of a treatment strategy with no curative intent (radiotherapy; chemotherapy; hormonotherapy; immunotherapy; targeted agents, non-curative surgery, ...)
• • Patient naïve of anticancer treatments in non-curative setting (except for metastatic hormone-sensitive prostate cancer, see specific inclusion criteria).
• The following tumor type specific inclusion criteria must be met in addition to the inclusion criteria listed above:
• • Breast carcinomas
• • All cohorts:
• • Invasive breast ductal carcinoma, or
• • Invasive breast lobular carcinoma
• * Curative intent treatment patient cohort:
• • Planned to be treated with surgery, with/without neo-adjuvant and/or adjuvant chemotherapy and/or anti-hormone treatment
• • Gastric carcinomas
• * All cohorts:
• • o Intestinal-type adenocarcinoma, or
• • o Diffuse cell type adenocarcinoma
• * Curative intent treatment patient cohort:
• • Planned to be treated with surgery with/without neo-adjuvant treatment, with/without adjuvant treatment
• Renal carcinomas • All cohorts:
• • Any histology of renal cancer is accepted (non-clear cell renal cancer could be included)
• • A pathology proof of renal cell carcinoma is not necessarily provided if patients present typical radiologic characteristics of renal cancer on imaging
• • Curative intent treatment patients cohort:
• • Planned to be treated with partial or total nephrectomy
• • Prostate carcinomas
• * Curative intent treatment patients cohort:
• • o Localized prostate cancer with high risk features : StageT2b , T2c or T3 and/or Gleason \>= 4+3 and/or PSA \>= 20 and/or N+
• • o Planned to be treated with radical prostatectomy or radiotherapy (potentially associated with androgen deprivation therapy). Brachytherapy and/or focused ultrasounds are not allowed.
• * Non-curative intent treatment patients cohort:
• • Patients with metastatic castration resistant prostate cancer (mCRPC) defined by validated criteria of EAU, planned to be treated with doceteaxel or cabazitaxel or second generation hormone (i.e. abiraterone or enzalutamide). Patients have to be naïve of treatment for the castration resistant mCRPC. Patients that previously received docetaxel or a 1st or 2nd generation hormonotherapy for their hormone-sensitive prostate cancer in metastatic setting can be included.
• Lung carcinomas treated by immunotherapy :
• • Non-curative intent patients cohort:
• • o NSCLC stage IV according to 8th TNM classification planned to be treated with immunotherapy, with/ without chemotherapy
• Lung carcinomas excluding those treated with immunotherapy:
• * Curative intent treatment patients cohort:
• • o NSCLC histology only
• • o Stage I-II according to 8th TNM classification
• • o Stage IIIA-B according to 8th TNM classification
• • o Planned to be treated with radical treatment (surgery or radiotherapy with/without concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant treatment
• * Non-curative intent patients cohort:
• • NSCLC or SCLC stage IV according to 8th TNM classification planned to be treated with a first line of chemotherapy, with/without associated treatments except immunotherapy (radiotherapy, targeted therapies...). Immunotherapy can be administrated for the subsequent lines of treatment.
• • Hepatocellular carcinomas A pathology proof of HCC is not necessarily provided if patients present typical radiologic characteristics of hepatocellular carcinoma on imaging
• • Absence or chronic hepatic encephalopathy, absence of refractory ascites
• * Curative intent treatment patients cohort:
• • Indication of a treatment strategy with curative intent, except liver transplantation: surgical resection, monopolar radiofrequency ablation for HCC (1 to 3 nodules ≤3 cm) or multibipolar radiofrequency if nodule ≤4 cm).
• • Non-curative intent patients cohort:
• • Indication of a treatment strategy with no curative intent: transarterial intra-hepatic chemoembolization, targeted therapies (tyrosine kinase inhibitors or monoclonal antibodies) or immune therapy.
• • Colorectal carcinomas
• • Curative intent treatment patients cohort:
• • o Lieberkühn adenocarcinoma associated with metastases planned to be treated with peri-operative chemotherapy +/- targeted agent and interval surgery
• • Head and neck carcinomas
• • All cohorts
• • o Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx, larynx
• * Curative intent treatment patients cohort:
• • o Planned to be treated with a radical treatment (surgery and/or radiotherapy potentially associated with concurrent chemotherapy) with/without neo-adjuvant/adjuvant chemotherapy.
• * Non-curative intent treatment patients cohort:
• • o De novo metastatic or metastatic/loco-regional relapse planned to be treated with chemotherapy and/or immunotherapy
• • Thyroid cancer • Curative intent patient cohort o Thyroid carcinoma differentiated, poorly differentiated, papillary, vesicular, Hurthle Cell o For which a iodine treatment is indicated (Iodine treatment will be discussed after surgery. In the case the histological result does not confirm a high risk thyroid cancer, patient will be withdrawn from the study. In the same way, if a iodine treatment is not recommended after surgery, patient will be withdrawn from the study. In both cases, patient will be replaced).
• • Pancreatic carcinomas
• • Curative intent patients cohort:
• • o Pancreas exocrine adenocarcinoma planned to be treated with initial surgery with/without neo-adjuvant chemotherapy and with/without adjuvant chemotherapy or radiotherapy
• Ovarian adenocarcinomas • Non/uncertain curative intent patients cohort:
• • o 1st platinum-sensitive relapse
• • High or low grade epithelial adenocarcinomas or carcinosarcoma
• • Planned to be treated with chemotherapy and/or PARP inhibitors based treatment, +/- interval debulking surgery
• Glioblastoma • Curative intent patients cohort:
• • o Planned to be treated with surgical resection, followed by adjuvant temozolomide and radiotherapy
• • Endometrial adenocarcinomas
• * Non-curative intent patients cohort:
• • o Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell, undifferentiated carcinoma and carcinosarcoma) cancers
• • o Planned to be treated with non-curative systemic treatment for metastatic or advanced disease
• • Bladder carcinoma
• * Transitional cell carcinoma • Curative intent treatment patients:
• • Patients with localized muscle invasive bladder cancer (\>=PT2)
• • Planned to be treated with neo-adjuvant cisplatin based chemotherapy, or immunotherapy or a combination of chemotherapy and immunotherapy
• Superficial Oesophago-gastric cancer • Curative intent patients cohort:
• • o Superficial oesophago-gastric carcinomas (adenocarcinomas or epidermoid carcinomas) of Stage T1 planned to be treated by endoscopic surgery
• • Diffuse Large B-Cell Lymphoma (DLBCL)
• • Curative intent patients cohort:
• • o Patients planned to be treated with R-CHOP (Rituximab-Cyclophosphamide, Hydroxyadriamycine, Oncovin, Prednisone)