Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer

Colorectal Neoplasms Clinical Trial

Official title:

Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01915225
• Other study ID #: 130176
• Secondary ID: 13-C-0176
• Status: Recruiting
• Start date: July 21, 2013

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Cathleen E Hannah, C.R.N.P.
• Phone: (240) 858-7006
• Email: foregut[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

• Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).

Objectives:

• To collect tissue samples for use in studying new ways to treat tumors.

Eligibility:

• Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC.

• Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care.

Design:

• Before their procedure, participants will have a small blood sample taken.

• Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours.

• For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis.

• Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.

Description:

Background:

Recent advances and insights into the molecular pathogenesis of cancer have led to the development of novel molecular and biologic targeted therapies for the treatment of advanced cancer patients. A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies.

As Surgical Oncologists at the NCI, we have an interest in identifying novel molecular and biologic targets to facilitate the development of future cancer therapies. In addition, we have the primary responsibility for providing surgical consultative services to the NIH. As such, we are uniquely positioned to acquire and perform important studies on solid tumor tissue to help identify therapeutic targets that may have significant clinical ramifications.

Objectives:

To collect biologic samples from patients undergoing diagnostic, preventative, or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets.

Eligibility:

Patients age >= 2 years and older with radiographic or clinical suspicion of, genetic predisposition for, biochemical evidence of, or histologically/cytologically proven solid neoplasms who require diagnostic, preventative, or therapeutic intervention as a part of the diagnosis and/or treatment and/or follow up for their neoplasm. Note: Patients >= 2 years of age and under 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood or urine does not add risk to the clinically indicated procedures.

Patients without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.

Patients should have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to planned intervention.

Design:

A tissue acquisition trial in which tissues will be obtained at the time of intervention.

No investigational therapy will be given.

It is anticipated that 1415 patients will be enrolled over a period of 10 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1415
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

• INCLUSION CRITERIA

• Patients must be 2 years of age or older. Note: Patients greater than or equal to 2 and < 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood and urine does not add risk to the clinically indicated procedures.

• Patients who have premalignant, primary or metastatic solid tumors based upon either radiographic or clinical suspicion, biochemical testing, a genetic predisposition, or histological/cytological analysis that requires surgery or biopsy as part of the diagnosis, prevention, treatment and/or follow up

• Patients without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.

• Patients should have laboratory and physical examination parameters within acceptable limits prior to biopsy or surgery.

• Patients must be planning to undergo surgery or biopsy as part of their normal treatment plan.

• Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

None

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Cholangiocarcinoma
• Colorectal Neoplasms
• Gastric Neoplasms
• Neoplasms
• Pancreas Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Gerlinger M, Rowan AJ, Horswell S, Math M, Larkin J, Endesfelder D, Gronroos E, Martinez P, Matthews N, Stewart A, Tarpey P, Varela I, Phillimore B, Begum S, McDonald NQ, Butler A, Jones D, Raine K, Latimer C, Santos CR, Nohadani M, Eklund AC, Spencer-Dene B, Clark G, Pickering L, Stamp G, Gore M, Szallasi Z, Downward J, Futreal PA, Swanton C. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med. 2012 Mar 8;366(10):883-892. doi: 10.1056/NEJMoa1113205. Erratum In: N Engl J Med. 2012 Sep 6;367(10):976. — View Citation

Longo DL. Tumor heterogeneity and personalized medicine. N Engl J Med. 2012 Mar 8;366(10):956-7. doi: 10.1056/NEJMe1200656. No abstract available. — View Citation

Yachida S, Jones S, Bozic I, Antal T, Leary R, Fu B, Kamiyama M, Hruban RH, Eshleman JR, Nowak MA, Velculescu VE, Kinzler KW, Vogelstein B, Iacobuzio-Donahue CA. Distant metastasis occurs late during the genetic evolution of pancreatic cancer. Nature. 2010 Oct 28;467(7319):1114-7. doi: 10.1038/nature09515. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets	Identification of novel molecular and biologic therapeutic targets	2 month
Secondary	Collection of detailed history, demographic, treatment data, and perioperative outcomes data related to surgical quality and safety in order to categorize and track the specific procedures.	Detailed history, demographic, treatment data, and perioperative outcomes data related to surgical quality and safety in order to categorize and track the specific procedures.	10 years

External Links

•   NIH Clinical Center Detailed Web Page