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OpenTrials
Completed

NCT Number: NCT02892786

Detection in Peripheral Blood of Circulating Tumor Cells in Patient With Head and Neck Squamous Cell Carcinoma

The dissemination of individual tumor cells is a common phenomenon in solid cancers. Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic situation is of high prognostic significance.

The objective of our study was to detect circulating tumor cells in two different method in patient with head and neck squamous cell carcinoma .

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Patient with head and neck squamous cell cancer stage III or IV histologically proven
  • Patient naive to any prior therapy
  • Patient with operate cancer and resectable tumor
  • Hemoglobin ≥ 10g / dL
  • Performance status ≤ 2
  • Ability to provide written informed consent
  • Patient's legal capacity to consent to study participation

Exclusion criteria

  • Other previous histology tumors
  • Medical conditions or acute or chronic severe psychiatric disorders
  • Deprived of liberty or under supervision

Treatment and study plan

Circulating tumor cells

Other

Patients with stage III and IV head and neck squamous cell carcinoma undergoing surgery were enrolled in this study

5 and 7.5 ml of peripheral venous blood will be taken before the surgery, just at the end of surgery and one week after surgery

Analysis was performed by RT-PCR and the CellSearch™ method using immunomagnetic and fluorescence approaches.

Patients will be followed every 3 months for two years.

Primary outcomes

  1. Circulating tumor cells in peripheral blood during head and neck surgery

    Time frame: 7 days

    The number of circulating tumor cells detected per milliliter of peripheral blood will be evaluated on the day before, the day of surgery and 7 days after the surgery.

Secondary outcomes

  1. Comparison between RT-PCR and CellSearch™ method

    Time frame: 1 day

    The comparison between RT-PCR and CellSearch™ method will be the positivity sample rate

  2. Prognostic marker of relapse

    Time frame: 2 years

    Local recurrence, regional or metastatic head and neck cancer in the two years

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Acronym: CTCVADS

Important dates

Study start
2010
Primary completion
2017
Study completion
2018
First posted
Sep 8, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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