Eye Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Ear, Nose, and Throat Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Rare Diseases

Cataract

Coronary Artery Disease

Heart Failure

Syndrome

Lung Diseases

Liver Diseases

Fatigue

Lymphoma

Leukemia

Heart Diseases

Hemorrhage

Communicable Diseases

Renal Insufficiency

Arrhythmias, Cardiac

Peripheral Nervous System Diseases

Hypersensitivity

Ischemia

Hypotension

Seizures

Myocardial Ischemia

Lung Diseases, Interstitial

Vertigo

Dizziness

Leukemia, T-Cell

Sleepiness

Thromboembolism

Hypothyroidism

Hypotension, Orthostatic

Confusion

Leukemia-Lymphoma, Adult T-Cell

Tumor Lysis Syndrome

Teratogenesis

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Adult T-cell Leukemia/lymphoma

Leukemia, T-cell, Chronic

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance

Revlimid

BMS Study Connect Contact Center www.BMSStudyConnect.com, Study manager

First line of the email MUST contain the NCT# and Site #.

Bristol-Myers Squibb

To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

1. Planned registration period 3 years
2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Number of participants with adverse events

Celgene

Lung Neoplasms

Neoplasm Metastasis

Multiple Pulmonary Nodules

Neoplasms, Second Primary

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

CT scans of patients with a new lung nodule(s) subsequently confirmed to be benign and in the context of a previous history of radically treated cancer, will be identified at participating NHS sites and recruited.

CT scans of patients with a new lung nodule(s) subsequently confirmed to be metastatic in nature and in the context of a previous history of radically treated cancer, will be identified at participating NHS sites and recruited.

CT scans of patients with a new lung nodule(s) subsequently confirmed to be a new second primary lung cancer and in the context of a previous history of radically treated cancer, will be identified at participating NHS sites and recruited.

First nodule detection CT scans as per eligibility criteria will be used as input into in-house software to extract multiple radiomic features and used to develop a machine learning based classifier to differentiate nodule aetiology. Scans will also be used as input in to a deep learning/convolutional neural network models to perform automated imaging classification.

Non-Interventional Study

Sejal Jain

Laura Boddy

Richard Lee

Hardeep Kalsi

Anand Deveraj

This study will assess the utility of radiomics and artificial intelligence approaches to new lung nodules in patients who have undergone radical treatment for a previous cancer.

Improvements in cancer detection and diagnosis have led to increasing numbers of patients being diagnosed with early stage cancer and potentially receiving curative therapy with improved survival outcomes. Recent retrospective studies in cancer survivors have demonstrated such patients possess an increased risk of further cancer in their lifetime compared to the general population, in part potentially due to shared lifestyle risk factors (e.g. smoking), genetic cancer pre-disposition or downstream oncogenic side effects of anti-cancer therapies (eg. radiotherapy). Lung cancer remains the leading cause of cancer related deaths worldwide and the lungs also represent a common site for metastatic disease in patients with non-pulmonary malignancy. Furthermore, lung cancer is one of the most common second primary malignancy in patients with a prior history of treated cancer. Therefore, discerning the significance of a pulmonary nodule in the context of a previous cancer remains a clinical challenge given it may possess the potential to represent benign disease, metastatic relapse or new primary malignancy.

This study will assess the utility of radiomics and artificial intelligence approaches to new lung nodules in patients who have undergone radical treatment for a previous cancer. This will entail use of machine learning (ML) approaches and later, exploration of deep-learning/convolutional neural network approaches to nodule interpretation for differentiation of benign, metastatic and new primary lung cancer nodules/lesions. Development of a ML classifier or deep learning based tool may help guide which patients would benefit from earlier investigations including additional imaging, biopsy sampling and lead to earlier cancer diagnosis, leading to better patient outcomes in this unique cohort. This is a retrospective study analysing data already collected routinely as part of patient care. All data will be anonymised prior to any analysis, no patient directed/related interventions will be employed and consent-waiver for study inclusion will be exercised.

AI & Radiomics for Stratification of Lung Nodules After Radically Treated Cancer

Artificial Intelligence & Radiomics for Stratification Of Lung Nodules After Radically Treated Cancer (AI-SONAR)

The study aims to identify distinct clusters of radiomics variables to generate a radiomics predictive vector (RPV), which can be used to stratify benign vs malignant nodules in patients who have previously received radical treatment for a malignancy. The RPV will be used in multivariate analysis and compared to existing risk models used in clinical practice.

The study aims to identify distinct clusters of radiomic variables to generate a radiomics predictive vector (RPV) which is able to differentiate metastatic lung nodules from new primary lung cancer in patients who have previously received radical treatment for a cancer. No current models exist in clinical practice which address this diagnostic challenge.

The investigators aim to assess performance of the derived radiomics predictive vector (RPV) on an external independent post-cancer lung nodule dataset to evaluate generalisability and potential real-world performance.

Institute of Cancer Research, United Kingdom

National Institute for Health Research, United Kingdom

Royal Brompton & Harefield NHS Foundation Trust

Royal Marsden Partners Cancer Alliance

Imperial College London

Oxford University Hospitals NHS Trust

National Heart and Lung Institute

Royal Marsden NHS Foundation Trust

Recurrence

Head and Neck Neoplasms

Quality of Life

Micronutrients

Vitamins

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Antioxidants

Carotenoids

Beta Carotene

Protective Agents

Trace Elements

Provitamins

Tocopherol

Tocotrienol

Patients received a daily supplementation of alpha-tocopherol (one capsule of 400 IU dl-alpha-tocopherol) and beta-carotene (one capsule of 30 mg) for 3 years after the end of radiation therapy. Due to ethical concerns, the beta-carotene supplementation was stopped during the trial (after the randomization of 156 patients). See details in JNCI, 2005: 97 (7), 481-8.

Patients received two capsules of placebos per day during 3 years. When the beta-carotene was stopped, they received only one capsule.

Alpha-Tocopherol and Beta-Carotene

Placebo

Isabelle Bairati, MD, PhD

Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of antioxidant vitamins and minerals are associated with increased risks of cancer, especially for epidermoid tumors. Patients with stage I or II head and neck cancer have a good prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site. However, the benefit of treatment is often compromised by the occurrence of second primary cancers, which develop in 20% of patients during the first 5 years after diagnosis. We conducted a randomized chemoprevention trial among patients with head and neck cancer treated by radiation therapy to determine whether supplementation combining two antioxidants, alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in this patient population (primary objective of the trial). This study was conducted with funds from the NCIC (#008176,004738,013211) and was completed.

In this cohort of head and neck cancer patients, we evaluated whether nine potential prognostic serum markers measured at the time of diagnosis were related to recurrence, occurence of second primary cancers and survival. This study was conducted with funds from the NCIC (#018100) and was completed.

Presently, we evaluate genetic polymorphisms(GWAS) associated with prognosis (NCIC grant #019502). We also assess the relationship between vitamin D (dietary intake, serum level, and genetic polymorphisms of key vitamin D-related genes) and head and neck long-term outcomes (NCI grant #1R03CA141615-01).

Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients

Without recurrence and without second primary cancer

Canadian Cancer Trials Group

National Cancer Institute (NCI)

Laval University

Professor (MD, PhD)

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Melanoma

Sarcoma

Retinoblastoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Soft Tissue Sarcoma

Neuroepithelioma

Retinoblastoma patients treated at two hospitals in New York and one hospital in Boston from 1914-2006.

Lindsay M Morton, Ph.D.

Retinoblastoma is a rare pediatric ocular tumor caused by germline and/or somatic mutations in the tumor suppressor gene RB1. Survivors of retinoblastoma, particularly those with the hereditary form of the disease (germline RB1 mutations) are highly susceptible to developing additional malignancies, which are a major cause of morbidity and mortality. Since 1984, REB has followed a cohort of 2136 (including 1,995 one-year) retinoblastoma survivors to investigate the contributions of treatment and genetic risk factors to second cancer etiology. The last systematic follow-up for second cancer incidence and cause-specific mortality was completed in 2009. As the cohort ages, we now propose to conduct another interview survey to collect information on newly diagnosed second cancers. Additionally, we propose to expand collection of germline DNA for additional molecular studies in survivors. Retinoblastoma survivors have now entered adult ages when epithelial tumors would be expected to occur with greater frequency. Given that the somatic mutations in the RB1 pathway have been identified in several epithelial tumors (bladder, brain, breast, esophagus, liver, lung, prostate) in addition to sarcomas, it is important to collect new information on these epithelial tumors, and to investigate whether the previously identified high risks of sarcomas and melanoma will persist as the cohort ages. Additionally, our understanding of genetic susceptibility to second cancers is limited. Given that this is the only cohort of long-term survivors of retinoblastoma being followed in the U.S., combined with the leadership role of REB in the study of second cancers, continued follow-up of this cohort will provide unique clinical and epidemiologic data on the long-term cumulative risk of second cancers in this distinctive cohort of childhood cancer survivors.

Retinoblastoma Biomarker Study

Risk of subsequent cancer in relation to prior treatment and RB1 mutation

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

no intervention

The objective of this study was to analyze the pathological factors influencing the occurrence and prognosis of SPC in CRC patients of varying ages and compare the differences in the patterns of SPC occurrence and prognosis among patients of different age groups.

Second Primary Cancer and Early-onset Colorectal Cancer

Risk Factors, Cancer Types and Prognostic Significance of Second Primary Cancer Based on the Early-onset and Late-onset Colorectal Cancer

The duration from the date of surgery to death for any reason or the last recorded follow-up, whichever comes first.

Up to 100 months

LI XIN-XIANG

professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
AI & Radiomics for Stratification of Lung Nodules After Radically Treated Cancer	NCT05375591	Indeterminate P... Lung Metastases Second Primary ... Lung Cancer	Non-Interventio...	18 Years -	Royal Marsden NHS Foundation Trust
Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients	NCT00169845	Neoplasms	Alpha-Tocophero... Placebo	18 Years -	Laval University
Retinoblastoma Biomarker Study	NCT00342797	Retinoblastoma Melanoma Sarcoma		7 Years -	National Institutes of Health Clinical Center (CC)
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
Second Primary Cancer and Early-onset Colorectal Cancer	NCT06423924	Colorectal Canc... Second Primary ...	no intervention	18 Years - 80 Years	Fudan University

Spots Global Cancer Trial Database for second primary cancer