Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

(Stool collection on newly diagnosed patients in this cohort) Participants will include patients under the age of 50 who are diagnosed with colorectal adenocarcinoma.

(Stool collection cohort only) 166 colorectal cancer patients 50 year-old or older will serve as controls.

Stool collection cohort only.

Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit

Risk Factor Questionnaire

Andrea Cercek, MD

Rona Yaeger, MD

Andrew Cercek, MD

The purpose of this registry study is to create a database-a collection of information-for better understanding young onset colorectal cancer. Colorectal cancer patients are considered to have young onset colorectal cancer if they are diagnosed with their cancer before the age of 50. Researchers will use the information from this database to learn more about how young onset colorectal cancer may be similar to or different from colorectal cancer that is diagnosed later in life. Researchers will also use information from the database for current and future research on young onset colorectal cancer.

Collection of Information to Better Understand Young Onset Colorectal Cancer

Young Onset Gastrointestinal Cancer Prospective Registry

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Memorial Sloan Kettering Cancer Center

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Adenoma

Adenomatous Polyposis Coli

Polyps

Nasopharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Adenomatous Polyps

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Herbal and Botanical

Curcumin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

Cola

Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Calcumin (Curcumin)

Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Three tubes of blood at visits 0, 4 and 12 months.

Blood samples

Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Sigmoidoscopy)

Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Biopsies (Upper endoscopy)

Marcia R. Cruz-Correa, MD. PhD

Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum.

Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.

Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.

Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number in patients with FAP.

To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp size in patients with FAP.

National Institutes of Health (NIH)

University of Puerto Rico

Director of Gastrointestinal Oncology

Curcumin

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Placebo (sugar pills)

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Placebo

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Puerto Rico

Region of Enrollment

Dr. Marcia Cruz-Correa

Number of Polyps

Size of Polyps

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Participants diagnosed with ovarian cancer

For cases, the study recruiter at the Trust will present this in the clinic. Controls will complete this online or at home when volunteering to participate. The participant questionnaire will be completed by the participant.

For cases, the study recruiter at the trust will complete this form together with the participant. Controls will not complete this form.

Clinical Questionnaire

James Flanagan, PhD

Approximately 7,400 new cases of ovarian cancer are diagnosed each year in the United Kingdom (UK), and with over 4,000 women dying from the disease each year it is a particularly lethal form of cancer. The symptoms for ovarian cancer are not well known and vague, and most women are diagnosed at a late stage when the cancer has already spread around the abdominal cavity with poor prognosis. Novel methods are needed to improve earlier detection and thereby improve survival from this disease.

The Cancer Loyalty Card Study (CLOCS) proposes to use loyalty card data from two participating high street retailers to investigate purchase behaviour as an opportunity for cancer symptom surveillance. The investigators aim to conduct a case-control study of ovarian cancer patients matched with women without ovarian cancer and to explore public preferences for how to communicate potential outcomes of the commercial and health data linkages back to individuals.

Eligible participants will be women in the UK who own at least one loyalty card with the participating high street retailers. Of these women, those who have been diagnosed with ovarian cancer are eligible to participate in the study as cases, while women who have not been diagnosed with ovarian cancer are eligible to participate as controls.

Upon choosing to participate, all participants will be asked to complete a short questionnaire about well-established ovarian cancer risk factors and common symptoms either in the clinic (cases) or online/from a packet in the mail(controls). This information will be used in risk assessment for ovarian cancer of participants, which will be used at the analysis stage.

Purpose and Design

The Cancer Loyalty Card Study (CLOCS) is addressing whether or not data already collected by high street retailers can detect significant changes in purchase behaviours of ovarian cancer patients prior to their diagnosis. The investigators aim to conduct a case-control study of ovarian cancer patients matched with women who do not have ovarian cancer. The study aims to recruit at least 500 recently diagnosed ovarian cancer patients and at least 500 healthy women as controls and collate up to 7 years of prior purchase data.

Recruitment

Loyalty card holders will be invited to join the study by email and post from the high street retailers and can choose to sign up via the CLOCS website or via post by returning the consent form to the study team through the mail. There will also be a press release about the study inviting loyalty card holders to visit the CLOCS website for more information and join the study. Women, 18 years or older, who have a loyalty card at the participating high street retailers are eligible to join. Women with ovarian cancer and who own at least one of the participating high street retailer's loyalty cards will be recruited in a clinic by a member of their healthcare team where the study is open. Any woman considering joining the study can contact the research team using the contact details on the information sheet.

Consent

Ovarian cancer patients will be given the information sheet and consent form in the clinic by a member of their healthcare team. They can take as much time as they need to read through the information sheet. If they choose to participate, they can complete the consent form whenever is convenient for them and return it to the CLOCS team in the free post envelope provided to them in the clinic.

Women without ovarian cancer will be presented with the information sheet and consent form in an email or letter in the mail from their high street retailer if they hold a loyalty card with them and return them to the CLOCS team in a free post envelope. They can also find the information sheet and consent form on the CLOCS website and consent online.

Methods

Consenting participants will complete a brief questionnaire about ovarian cancer risk factors, which will also be returned to the CLOCS team through the mail or on the website (healthy volunteers only). Participants with ovarian cancer will also have a clinical form for a member of their clinical team to complete in the clinic. This will be sent to the CLOCS team along with their consent and risk factor questionnaire in the free post envelope. Two ovarian cancer patients have reviewed all questionnaires and CLOCS documents and expressed their approval. Women without ovarian cancer from the general UK population have also reviewed the risk factor questionnaire and expressed their approval saying the questionnaire is 'easy to understand' and 'straightforward'.

If participants consent to be re-contacted by the CLOCS team for future studies or for loyalty card detail clarification,they will provide either a contact email or phone number. There is no further action needed from participants once they complete their consent form and questionnaire (and clarify loyalty card details if necessary)

Cancer Loyalty Card Study

Cancer Loyalty Card Study: a Retrospective Observational Case-Control Study

Only aggregated and anonymised survey data will be shared with other researchers after publication. No sensitive individual level data will be shared.

The primary outcome of the CLOCS will be to define the time by which the cases and controls are statistically significantly different in their purchase behaviors leading up to diagnosis.

The secondary outcome of the CLOCS will be defining a purchase threshold as an "alert" about cancer symptoms in individuals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Collection of Information to Better Understand Young Onset Colorectal Cancer	NCT04489238	Colorectal Canc... Colorectal Carc...	Risk Factor Que...	18 Years -	Memorial Sloan Kettering Cancer Center
Collection of Information to Better Understand Young Onset Colorectal Cancer	NCT04489238	Colorectal Canc... Colorectal Carc...	Risk Factor Que...	18 Years -	Memorial Sloan Kettering Cancer Center
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)	NCT00927485	Familial Adenom...	Calcumin (Curcu... Risk Factor Que... Blood samples Biopsies (Sigmo... Biopsies (Upper...	21 Years - 85 Years	University of Puerto Rico
Cancer Loyalty Card Study	NCT03994653	Ovarian Neoplas...	Risk Factor Que... Clinical Questi...	18 Years -	Imperial College London
Collection of Information to Better Understand Young Onset Colorectal Cancer	NCT04489238	Colorectal Canc... Colorectal Carc...	Risk Factor Que...	18 Years -	Memorial Sloan Kettering Cancer Center

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