NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-C-0176

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Tissue Procurement;
Surgery;
Metastasectomy;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Colorectal Neoplasms;
Gastric Neoplasms;
Cholangiocarcinoma;
Bile Duct Cancer;
Pancreas Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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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


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Citations:

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.

Longo DL. Tumor heterogeneity and personalized medicine. N Engl J Med. 2012 Mar 8;366(10):956-7. doi: 10.1056/NEJMe1200656.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jeremy L. Davis, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3742
10 CENTER DR
BETHESDA MD 20892
(240) 858-3731
jeremy.davis@nih.gov

Cathleen E. Hannah, C.R.N.P.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5740
10 CENTER DR
BETHESDA MD 20892
(240) 858-7006
foregut@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01915225

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-C-0176

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Tissue Procurement;
Surgery;
Metastasectomy;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Colorectal Neoplasms;
Gastric Neoplasms;
Cholangiocarcinoma;
Bile Duct Cancer;
Pancreas Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

--Back to Top--

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


--Back to Top--

Citations:

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.

Longo DL. Tumor heterogeneity and personalized medicine. N Engl J Med. 2012 Mar 8;366(10):956-7. doi: 10.1056/NEJMe1200656.

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.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Jeremy L. Davis, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3742
10 CENTER DR
BETHESDA MD 20892
(240) 858-3731
jeremy.davis@nih.gov

Cathleen E. Hannah, C.R.N.P.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5740
10 CENTER DR
BETHESDA MD 20892
(240) 858-7006
foregut@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01915225

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